To

The Members,

Your Directors have pleasure in presenting their Report on the business and operations of the Company along with the Standalone and Consolidated Audited Financial Statements for the year ended March 31, 2024.

Financial Summary

(All figures are in Rupees in Lakhs)

REVIEW OF OPERATIONS:

During the year under review, the Company reported standalone operating revenues of C30,978.67 Lakhs as against C24,770.20 Lakhs and Total Comprehensive Income of C 2,528.11 Lakhs as against C 6,147.89 Lakhs in the previous year, consolidated gross revenues for the year review were reported at C 1,15,160.30 Lakhs as against C 1,05,011.24 Lakhs and Total Comprehensive Income/ (loss) of C2,950.36 Lakhs as against C (2,924.98) Lakhs in the previous year.

SHILPA PHARMA LIFESCIENCES LIMITED (Wholly owned subsidiary)-API FACILITIES

Shilpa has two world class State-of-art API manufacturing facilities at Raichur, supported by strong & efficient team of R&D, IPM, Production, Engineering, Quality Control,

Quality Assurance, Corporate Quality Assurance and Regulatory functions with other supportive functions & well administered Human Resource management. The facilities are cGMP Complaint & approved by many national & international regulatory bodies like USFDA, EU, Cofepris- Mexican, PMDA-Japan, Korean FDA, TPD Canada, TGA-Australia & ANVISA Brazil

The Company is having about 20 API's & intermediate manufacturing blocks with segregation of Oncology and Non-Oncology manufacturing facilities. Oncology products are manufactured & handled with high level of containment & taking care of people & environment. Oncology Blocks designed to handle small scale, medium scale & high-volume scale to handle different levels of Batch size like 500 gm to 350 kg and Non-Oncology batch sizes from 4 kg to 2,000 kg.

The API facilities are certified for ISO9001:2015 for quality Management systems, ISO14001:2015 for

Environmental management systems, ISO45001:2018 for occupational health & safety systems,ISO50001:2018 for Energy Management Systems & SA8000:2014 for Social accountability Management system & R&D is certified by DSIR, Govt. of India.

Shilpa is the first Company to invest in India on containment technologies for the manufacturing of oncology drug substances in a contained environment & also latest technologies like Bipolar system from Japan to ensure the manufacturing process are sustainable with less consumption of natural resources & safe operations, we have expanded with 2nd system in FY2023-24. These innovative Technologies provide us the sustainable process which are validated & commercialized. Adopting these novel technologies makes the Company conserve the resources & make our processes environment friendly and give the Company an edge in penetrating the new markets & innovator companies.

As an environmentally conscious Company , we focus on reduce, recycle& reuse of the wastes generated. The Company recycles 100% waste water by treating in its Zero liquid discharge effluent treatment plant. The Company reduces the resource usage for treatment by segregating the liquid wastes based on the TDS&COD. The Company monitors & controls scope-1, scope-2 & scope-3 emissions. The fugitive emissions from the reactors are effectively scrubbed , all the storage facilities solvents are connected to the heat exchangers with chilled water to prevent the air pollution due to evaportaion from the storage tanks . The air quality is monitored in the premises work areas are monitored for Volatile Organic Content & effective control measures are in place to keep the emissions in control. The Company has reduced the emissions to the extent of about 10000 Tons of GHG emissions year on year by using the renewable fuel Biomass in place of the Fossil fuel for its thermal energy requirements. This project was registered with UNFCC. The Company is UNGC participant & submitted its performance for the FY-23-24 , & is listed on their site. The Company is signatory to SBTI( Science based Targets Initiative ) by committing to become Net Zero by the year 2040. The Company undertakes the targets for the reduction of the wastes & resourse usage by the involving the whole site team.

The solvents are recovered, purified and reused in its processes and reduces the resource usage, both the facilities are equipped with fractional distillation columns .

The Company strongly believes in sustainable growth by focussing on the ESG systems. All the employees are trained on the ESG aspects. Risks are assessed and mitigation measures and recommendations are implemented by conducting HIRA, Hazop, IH, Process safety modules review. The necessary infrastucture for fire fighting and loss prevention is in place.

The Company understands the importance of involvement of its own employees as the drivers for ensuring the safe operations at the sites & nominated the safety Co-ordinators , safety squad & emergency response teams . The best training is imparted by external subject experts, state level Fire authorities and practicing the emergency procedures by mockdrills. These drills are monitored by District Authorities. The Company has hired Subject matter expert to advise and guide the operational team on ESG aspects and ensure the compliance.

The API Facilities are equipped with all the utilities to support the process requirements like wide range of temperatures from -50?C to 300?C, purified water, HVAC, clean rooms, nitrogen, compressed air.

The Utilities performance w.r.t capacity, efficiency are monitored by well trained personnel supported by original equipment manufacturers with a deep drive towards energy conservation.

The state of art Quality Control Facility is well equipped for testing and release of Finished goods, Raw Materials, Intermediates, with QMS in place.

The Company has made utilisation of the existing capacity more effectively by bifurcating the intermediate areas into two bay system, to run the two products at the same time with out cross contamination, thereby the opportunity of manufacturing multiple products at a time.

The Company is creating additional capacity 10MT per month for one of its niche molecule Tranexamic Acid, from the current capacity of 14MT per month. This expansion activity will start will commence the production from Jan 2025.

In the FY2023-24 the Company's strong hold product Ambroxol Hcl capacity was increased from 135 MT to 175MT per annum by optimally utilising the ambroxol manufacturing facility and by making the manufacturing equipment into two bays, and the capacity enhancement to 230MT is underway by debottlenecking of some of the equipment within the same facility.

Shilpa proved its Capability and Capacity manufacturing and selling about 175MT Ambroxol and 165MT Tranexamic acid.

The Company has added new manufacturing facility in the existing premises with about 85 KL volume with higher size reactors to ensure UDCA scale is increased and business volume enhanced from 48MT of FY 2022-23 to 100 MT in FY 2023-24 and planning to further expand to 150 MT in FY 2024-25.

Polymer R&D & Peptide R&D of Shilpa is fully functional & started commercial products. One of our Polymer Products transformed to commercial scale which will have substantial addition going forward. The Company has filed CEPs for the 2 No's of peptide molecules with this Shilpa stepped up in Peptide & extended its wings in regulatory market in this new segment.

SHILPA PHARMA -R&D (API)

As an essential part of its business strategy, the Company sees its consistently excellent R&D skills as what allows it to consistently develop new medicines and offer a long- term, sustainable competitive advantage. As one of the few Indian pharmaceutical firms with a strong R&D foundation, the Company is committed to mastering a variety of chemistries and value chains to meet its worldwide regulatory aspirations. The Company is committed to being a leader in the specialty API and oncology generics markets, which is reflected in its R&D environment. By introducing generic medications to the market as soon as possible and making them accessible to as many patients as possible, our generics business helps to lower drug prices for individuals and governments. This is accomplished by mastering multiple chemistries and value chains. We provide affordable, superior medicine.

The Company will keep up its major efforts to support affordability, aim to diversify its generic product line, and concentrate on boosting accessibility to goods with high entry barriers. We will continue searching for fresh approaches to expand the patient base for generics, working with multinational players to establish long-term manufacturing relationships.

Our research and development center's proficiency in managing diverse chemistries, including grignard, organolithium, organometallic, and cross-coupling reactions, provides room for the creation of innovative generics that adhere to global regulatory standards. This includes complex API generics that are challenging to make like those for the oncology / non-oncology space.

The effective flow chemistry team at the Company is working hard and has successfully demonstrated two products in the market. In FY2024-25, they plan to demonstrate a pipeline of four more products. This is where close handling really shines.

With a robust R&D foundation, Company began synthesizing the essential impurities needed for the development of new APIs as well as those needed to set up an effective control strategy and resolve regulatory DMF deficiencies for Drug Master Files (DMFs) that were filed, all in an effort to save time and money.

The R&D department helps the Company consistently develop new products and provide alternatives to the KSMs and Intermediates that are being imported in bulk from China. By focusing on the downstream chemistries, the R&D team began working toward self-reliance on KSMs and intermediates.

In order to save production costs, achieve global leadership, and achieve sustainable growth, Shilpa R&D consistently concentrates on new technologies and efforts to improve the commercialized APIs' processes.

Shilpa Medicare Limited - Finished Dosage Formulation Facility is a state of the art manufacturing and testing facility, engaged in manufacturing and distribution of potent drugs- which includes liquid and lyophilized injectables in vials, sterile dry powder injectables in vials, oral solid dosage form (Tablets and hard gelatine capsules) into various regulated and rest of the world markets, including US and EU.. The facility is designed for handling of potent Drug Products (including Oncology products or adjutant therapies) in a fully contained manner. Facility is designed to handle potent molecules up to OEL 4 level of containment.

The facility is approved by various regulatory agencies, including EUGMP-AGES-Austria, ANVISA, Health Canada, Peru, Argentina, South Africa, COFEPRIS Mexico, TGA -Australia, Ministry of Health- UAE & UKMHRA.

For USFDA, currently the facility is under Import Alert, however; USFDA has exempted three products from the Import Alert. Shilpa Medicare Unit 4 is distributing these three products (Azacitidine for Injection, Erlotinib Capsules and Cyclophosphamide Capsules), in the US market. Supplies to Europe are going on uninterrupted.

This facility consists of Oral Solid Block with two commercial scale tablet manufacturing and one commercial scale capsule manufacturing line. There are two blister packing lines and one Bottle filling line.

Fully automatic packaging lines are available for Injectables in vial presentation and for Oral solid dosage forms in bottles and blister presentations. The Injectable Packaging lines are designed for safe packaging for Onco Injectables.

Serialization (Track and Trace) is in place and implemented as per market requirement for commercial supplies.

The facility is supported by state of art utilities like purified water, WFI, pure steam, chillers, air compressors, Boilers , Power generators & HVAC , helping the Company to ensure the compliance in process & work environment.

All world class process equipment are provided with 21 CFR part 11 compliant SCADA systems.

Fully equipped and approved chemical testing Laboratories and Microbiology laboratory are operational with trained and qualified staff.

Commercial presence in various regulated, emerging markets and domestic markets in injectable and oral solid dosage forms.

Capacities:

Liq. Inj. - 12.6 million/Annum.

Lyo. Inj.- 2.32 million/Annum Dry powder Inj.- 0.67 million/Annum Tablets: 33.5 million/Annum Capsules: 27 million/Annum.

Contract Manufacturing

Shilpa Medicare Limited manufactures many products in several types of dosage forms such as tablets, capsules, liquid injection (Aseptically and terminally sterilized), Lyophilized Injectable, etc for various reputed pharmaceutical organisations across the world.

All products are manufactured under the same stringent quality standards for export to USA, EU, EM and Domestic market.

REGULATORY FILINGS (API RAICHUR UNIT-1 & UNIT-2) FY- 2023-24

Regulatory Inspections and approvals (API units) FY- 2023-24

REGULATORY FILINGS (FORMULATION UNIT) FY- 2023-24

Regulatory Inspections and approvals -Formulation Unit

Regulatory Inspections and approvals- Unit-VII, ASD.

Regulatory inspections and approvals (Unit 6, Bangalore):

SHILPA MEDICARE LIMITED INTELLECTUAL PROPERTY MANAGEMENT (IPM)

The Intellectual Property Rights (IPR) Department at Shilpa Medicare Limited caters to Shilpa and its group companies. Our IPR department plays a critical role in safeguarding the Company's innovations and creative works. Our team is dedicated to managing and protecting our patents, trademarks, copyrights, trade secrets, and other intellectual property assets. By doing so, we ensure that our competitive edge is maintained and our brand integrity is upheld. Our IPR Department works closely with R&D, legal, and marketing teams to develop strategies that align with our business objectives and support our growth.

Key Responsibilities:

Patent Management: Overseeing the filing and maintenance of patents to protect our technological advancements.

Trademark Protection: Ensuring our brand identifiers are registered and defended against infringement.

IP Litigation: Handling disputes and litigation to defend our intellectual property rights.

IP Strategy Development: Crafting policies and strategies to maximize the value of our IP portfolio.

Increased Patent Portfolio:

Successfully filed 9 new patents, taking the cumulative total to 563 patents and pending applications in India and other countries.

Shilpa received grant of 16 patents in India and other countries including the US, Europe etc, expanding our global reach and protection.

Trademark Registrations:

Filed 9 new trademark applications and obtained registrations for 10 trademarks from Indian trademark office, enhancing our brand presence in India domestic market.

Achieved a 100% success rate in defending against trademark infringements.

Litigation Successes:

Successfully obtained an injunction against a domestic Indian Company in relation to Shilpa's patent, which was issued and covers dispersible tablets of Capecitabine.

Looking Ahead:

As we move forward, Shilpa remains committed to enhancing our IP management capabilities and supporting the Company's strategic goals. We will continue to focus on expanding our IP portfolio, leveraging our assets through strategic partnerships, and maintaining rigorous enforcement of our rights. Our ongoing efforts will ensure that Shilpa Medicare Limited and its group of companies remain at the forefront of innovation and market leadership.

Shilpa Medicare Transdermal Patches & Oral Film Manufacturing Plant (Unit VI)

A transdermal patch is a medicated adhesive patch that is placed on the skin to deliver a specific dose of medication through the skin and into the bloodstream. Transdermal patches have made their place in the global market in the past few decades as an alternative to conventional therapeutic for various disease indications. Transdermal patches are widely accepted among physicians and patients due to their non-invasive, pain free and easy administration. In recent years, the growth of the transdermal patch market has increased and is expected to increase significantly in coming years. Higher investments in research and development could be attributed to the success of the transdermal patch market.

Similarly, the oral thin film drugs were recorded with high market acceptance due to its ease of application and high effectiveness. Moreover, developed economies such as the U.S. and countries in Europe recorded significant sale of oral thin film drugs. The oral thin film drugs achieve the desired therapeutic results. Therefore, they have gained attention in the market as a potential treatment option.

Looking to the market potential, facility is designed and build a state of art Manufacturing facility of Transdermal Patch and Oral Thin Films at Bangalore. This facility shall cater to the Global Regulatory Market.

The layouts confirming cGMP requirements are finalized along with Utility, Administration, and canteen building. The equipment's are designed to cater both Transdermal Patch and Oral Thin Film Products. Space for future expansion is allocated for capacity increment.

Transdermal System / Patch (TDS) and Oral Dispersible Film (ODF) Manufacturing Plant status highlights:

• Transdermal Patch and Oral Film Manufacturing Facility is a Qualified GMP facility to manufacture exhibit batches filling product filling and commercialized in Global market. This facility is approved by MHRA (UK) for ODF products.

• We have completed execution of Exhibit/filing batches of Ten ODF products and one Transdermal product which includes strength wise 104s batches. We have filed an ODF product in UK MHRA which is got approval in 2023. The rest of the products are under Clinical studies and stability studies and will be ready to file for different countries in the coming months.

• We have got GMP certification program for Dietary Supplements (ODF) from UL Verification Services Inc.; Pennsylvania 18106; United States of America.

• We have ISO 5001:2018, ISO45001:2018 and ISO 14001:2015 Certification from AQC Middle East LLC, Noida, U.P. India and ISO / IEC 27001:2013 Certification from KVQA Certification Services Pvt Ltd Delhi, India

• We have Manufacturing Site Registration Certificate from Ministry of Health, UAE

• Site is approved by TGA Australia and Commercial Orders from well known clients are in pipeline.

• We have COPP/WHO Licence to manufacture for sale (or for distribution of) drugs other than those specified in [Schedules C and C(l) and X]

• We have many Nutraceutical ODF products / Sublingual film products / TDS in the development pipeline which are close to scale up and at different stage of development pipeline for Global market.

• These ODF Products are filed in multiple regulated as well as non-regulated markets and commercial agreements with multiple clients are in progress.

• Transdermal product agreements with European clients is done, product is under stability and filing is expected in end of 2024.

API Business Plan

Over the past decade, India has emerged as a key player in the API sector, following regulatory shifts in China and subsequent disruptions in the global chemicals supply chain. Benefiting from robust chemistry expertise and advantageous business conditions such as competitive labor costs, adherence to environmental and safety regulations, and international regulatory certifications, India's API industry has garnered attention from global generic pharmaceutical companies.

The recent challenges in supply chains due to the Covid-19 pandemic and resulting logistical hurdles have further solidified India's reputation as a dependable source of APIs. In 2022, the global API industry was valued at approximately USD 222.4 billion, with projections suggesting a steady growth at a CAGR of around 6% from 2023 to 2030, reaching USD 353 billion by 2030. Merchant APIs are expected to account for 40% of this market, with specialty small molecules representing close to 14% by value.

By FY25, domestic API consumption in India is anticipated to reach USD 21 billion. The growth of the API market can be attributed to advancements in manufacturing capabilities, coupled with an increase in the prevalence of chronic diseases such as cardiovascular ailments and cancer. Supportive government policies and changes in geopolitical dynamics are also contributing to the industry's expansion.

Despite significant API imports from China, particularly antibiotics, and China's dominance in export markets, global generic companies are adopting a "China + 1" strategy, which is expected to boost exports. Simultaneously, initiatives like backward integration and the Government's Production Linked Incentive (PLI) scheme are likely to reduce reliance on imports and stimulate domestic production.

In 2023 globally CDMO business is valued around @ 146 billion dollars, which is segregated across the globe, China is responsible for 27 billion dollars and India @ 15.63 billion dollars. The opportunity is huge to act as a reliable, trustworthy CDMO player.

Shilpa with its technological capabilities, process efficiencies, high quality manufacturing standards and facilities meeting regulatory standards of all major markets, occupies a sweet spot in the API and CDMO industry. With global spending on treatment for cancer on the rise, Shilpa has a role to play in offering cost competitive oncology APIs to the global generic industry and thereby try and reduce the cost for patient treatment. The Company focusses on sustainable growth through continuous cost reduction measures. With 9 dedicated oncology manufacturing blocks and multi product capability, we are ready to meet the growing demand for oncology APIs.

While we continue to develop new oncology APIs to meet the demand for off patent products, we are also now developing a range of non-oncology API molecules to cater to the growing outsourcing demand from India. 8 production blocks cater to this segment.

Shilpa is investing heavily on API R&D and augmenting its capabilities across various API segments (Peptides, niche oncology, Intermediates). The API business is expected to grow on account of increased capacity and backward integration which will lead to operational efficiencies.

Leveraging on existing infrastructure and geopolitical situation Shilpa has an incremental opportunity to support CDMO business. It needs to further strengthen and R & D more competent. Develop state of art infrastructure for Drug Substance and Drug Product.

Shilpa' s commercialization of Polymers and Peptides would also lead to incremental revenues and offer a complete range of services in Generics and CDMO space.

Shilpa has the requisite approval from Health Authorities to sell APIs in the regulated markets. With 21 valid CEP certifications and 45 active US DFMs and more on the anvil, Shilpa is well poised to grow business in this segment of the market. A strong pipeline of APIs at various stages of development will contribute to the growth of business year on year. The Company maintains the most stringent quality standards for all its products.

Our wide range of APIs, early entry opportunity for customers due to non-infringing chemistry and supply security, will position Shilpa as a preferred partner for API supplies. Our long-standing relationships with existing partners, whom we have supported in establishing leading market positions, will help enhance our share of business with them.

With a large number of products in Shilpa's API portfolio getting genericized between 2025 and 2028, we expect business from commercialization of these molecules to sustain our growth momentum. Attaining cost leadership, product differentiation, backward integration, customer centric approach will form the pillars of our business strategy.

US CDMO Business Plan Introduction

The Pharmaceutical Contract Development and Manufacturing Organization (CDMO) market is estimated at USD 243.29 billion in 2024, and is expected to reach USD 331.98 billion by 2029, growing at a CAGR of 6.41% (Mordor Intelligence, 2024). The CDMO market revenue in the largest market - United States - was valued at USD 54.21 billion in 2023 and expected to reach USD 68.32 billion by 2028, growing at a CAGR of 4.74% (Mordor Intelligence, 2024).

Small molecule API development and manufacturing for novel chemical entities (NCEs) are expected to be the dominant segments in the CDMO market with a revenue share of ~50% in 2018. Large molecules, such as biologics, biosimilars, cell and gene therapies, are expected to witness the fastest growth over the next 5 years. Among global markets, North America will maintain the lead due to the presence of some of the largest industry players, focus on innovative R&D into new treatments, increasing aging population, prevalence of chronic conditions emergence of new diseases, as well as the relative abundance of funding from venture capital for undertaking the high-risk novel drug discovery research effort. High R&D costs, capacity and capability limitations and specialized expertise - all major constraints within

pharma companies big and small - make CDMOs excellent external innovation partners to sponsors for expediting the drug manufacturing process while offering significant time, cost, and process efficiencies.

Shilpa Medicare Ltd. (SML) can expect rapid growth in the CDMO business due to its high-quality workforce, cost advantage in research and development (R&D) and manufacturing, and expertise across a range of industry verticals. In particular, SML's capabilities in drug substance (small molecules and large molecules) development and manufacturing, finished drug product development and manufacturing, as well as therapeutic peptides, polymer science and performance materials, makes a compelling case for the Company to become firmly established as a partner of choice for a wide range of companies across pharma and non-pharma segments.

Market strategy

Shilpa Medicare is a fully integrated Company providing DS, DP development and cGMP manufacturing from USFDA, Health Canada, EMA, PMDA, KFDA, Cofepris, and TGA accredited facilities. It is therefore well positioned to become a trusted and truly end-to-end solution provider given existing infrastructure and continuous capital- intensive investments.

(1) Leveraging exquisite strengths in complex chemistry across pharma and specialty chemicals

(2) Integrated CMC approach for delivering drug substance and drug product to pharma customers

(3) Strengthening of biologics business with a focus on monoclonal antibodies, fusion proteins and ADCs

(4) Technology focus with addition of niche capabilities such as flow chemistry and AI-DD

As an external innovation partner to the innovator biopharma industry, the Company bring differentiation at several levels that sets it apart in the CDMO industry -

(1) Early phase to late phase from AI/ML led discovery (target to hit, hit to lead and lead to NCE) to custom synthesis, scale up and clinical materials (for advanced intermediates, RSMs)

(2) cGMP manufacturing with multi-metric ton commercial manufacturing capacities for advanced intermediates, RSMs and final API, incl., oncology, high potent (OEL Band 5) and cytotoxic compounds

(3) Flow technology with the ability to conduct asymmetric catalysis, fluorinations, nitrations and a range of hazardous/complex chemistries

(4) Process intensification using custom printed reactors that offer exceptional COGS benefits over commercial flow reactors

(5) AI/ML based process R&D that yields optimized ROS, higher selectivity and purity, and reduction of unwanted by-products and impurities (e.g., NDMA)

In addition, Shilpa enjoys a unique position - on one hand - as a pharma Company first by combining both commercial and regulatory experience with successful registrations of >40 complex products globally incl., in the US and EU markets. On the services side on the other hand its experience in route scouting, synthetic chemistry, process and analytical development, ICH stability, product formulation, manufacturing, fill-finish, labeling and packaging offers customers a truly integrated approach to drug R&D. That combined with a structured program management approach assures customers of full support and high-quality execution from lab to clinic to market.

We will follow a fundamentally partnership driven approach to the market with a focus on brand building, innovation, impeccable delivery, and long-term supply chain assurance as the key pillars of customer engagement and success. We will follow a Deep Science methodology based on deep know-how of clients' clinical pipelines, chemistry and biology that will position Shilpa as a research driven CDMO and facilitate the acquisition of net new logos. We will establish a Program Management approach to delivery that transitions clients from a PO based practice to a full ownership and full lifecycle model and assure Speed to Clinic and Speed to Market. We will create a Pharmaceutical Sciences Platform that offers clients a full-value chain solution incorporating integrated CMC and program delivery from lead selection to IND within 10-12 months where technical teams will work across functions to ensure knowledge retention from early to late phase incl., scale up, clinical trial materials and cGMP manufacturing. We will establish a Governance Framework to ensure tight integration with key stakeholders (client sponsors, technical, clinical, quality, regulatory, commercial heads) with the objective to evolve from a project-based into a long-term value- based partnership and ensuring consistent delivery.

We will develop and execute consistent omnichannel (print and digital) marketing campaigns to evangelize Company's capabilities (website, email, print and video), incl., Japanese language messaging on LinkedIn and other social media channels. We will utilize sales automation and analytics to derive actionable intel and insights on markets and customers (e.g., dormant accounts, underserved territories, BD productivity metrics, win/loss stats, and so on).

(1) Small molecules: The US Food and Drug

Administration (USFDA) approved 53 new molecular entities (NMEs) in 2020, of which 40, or 75%, were small molecules. Accordingly, a major focus for the Company will be to strengthen its position and penetration in this segment. Shilpa provides a fully integrated CDMO services covering drug substance, drug product development and cGMP manufacturing from our USFDA, Health Canada, EMA, PMDA and TGA accredited facilities. Our expertise covers custom synthesis, chemical development, clinical materials, scale-up and cGMP commercial scale production of advanced intermediates, RSMs and API, incl., high potency, oncology and cytotoxic compounds. As oncology specialists, we bring significant experience in the development and manufacturing of tyrosine kinase inhibitors such as Axitinib, Dasatinib, Erlotinib, Imatinib, Lenvatinib, Nilotinib, Pazopanib, Sorafenib, Sunitinib and others, and a portfolio of anti-cancer compounds (e.g., Bortezomib, Cabazitaxel, Capecitabine, Decitabine, Enzalutamide, Gemcitabine, Pomalidomide, Temozolomide, to name a few). With these unique capabilities, the CDMO business has picked up a number of innovator biopharma companies in its portfolio of clients and delivered successfully on complex programs.

(2) Large molecules: The global biologics market was estimated at USD 511.04 billion in 2024 and is projected to hit USD 1,374.51 billion by 2033, growing at a CAGR of 10.4% from 2024 to 2033 (Nova One Advisor report,2024). Rising burden of cancer, genetic, neurological and autoimmune diseases and approval of novel biologic drugs such as gene therapies, RNAi therapeutics, and antibody-drug conjugates as well as advancements such as personalized medicine and companion diagnostics which allow for targeted treatments, have increased the demand for biologic products (Grand View Research, 2024). Monoclonal antibodies account for the largest number of biologics approved. Next-generation constructs such a bispecific antibodies, antibody fragments, radio- immunotherapies, nanobodies, and antibody-drug conjugates are driving the growth of this segment.

Shilpa Biologicals from its fully integrated facilities in Dharwad, Karnataka, India provides drug substance and drug product development and manufacturing for global markets. The facilities are fully equipped with state-of-the-art upstream and downstream processing for mammalian and microbial systems for monoclonal antibodies (MAbs), fusion proteins as well as adenoviral and AAV based gene therapies and vaccine production. This includes three lines for mammalian cell culture with 3x1KL single use bioreactors, 2x2KL single use bioreactors and 10L and 40L ATF systems along with three filling lines incl., a high throughput line with capacities of 300u/m liquid vial fill (for vaccines). In microbial fermentation, we have 2x independent trains with 2KL capacity (for E.coli and Pichia pastoris) and a greenfield project of 220KL SS bioreactor capacity. Notably, we provide the full complement of services from cell line / clone development, and cGMP cell banking to manufacturing, fill/finish (in vials and PFS), packaging and labeling -

(1) CHO cells for MAbs, fusion proteins, glycoproteins and subunit vaccines

(2) HEK cells for adenoviruses and adeno- associated viruses

(3) Pichia pastoris for VLP, antigen and heterologous protein production

(4) E. coli for DNA vaccines and high purity DNA plasmids (for mRNA vaccines)

Our expertise stems from extensive hands-on development of molecules such as recombinant human albumin, an NBE, biosimilars such as adalimumab, etanercept, aflibercept and abatacept, as well as vaccine manufacturing (e.g., from HEK293 and E. coli for Covid-19 and high purity DNA plasmids for mRNA vaccines). In addition, we have developed recombinant human albumin (rHA) in-house as a superior substitute as compared to what is available from natural sources such as plasma which carries risk of contamination from biological agents and pathogens. Several companies have shown interest in a strategic collaboration with us on rHA with immense commercial potential for the Company.

(3) Therapeutic peptides: The global peptide therapeutics market is forecasted to exceed USD 101.7 billion by 2033, with a CAGR of 9.1% from 2024 to 2033 (Market.us, 2024). Peptide therapeutics consist of drugs composed of short or long chain amino acid chains designed to target specific disease states and offer advantages over small molecule drugs, such as high selectivity, specificity, low toxicity, and favorable pharmacokinetics. Several peptide drugs have reached the market for diseases such as cancer, multiple sclerosis, diabetes, osteoporosis, chronic pain, and HIV infection. This is a high growth market due to advancements in peptide design technologies, incl., use of bioinformatics and systematic biological approaches, rising R&D investments in peptide-based therapies, and inherent favorable properties such as high specificity and tolerability. Recent product approvals in this space include Semaglutide, the active ingredient of blockbuster Novo Nordisk drugs Ozempic? and Wegovy?, for treatment of type 2 diabetes and long- term weight management. Semaglutide is a peptide similar to the hormone glucagon-like peptide-1 (GLP-1), modified with a side chain.

Shilpa is extremely well positioned in this space given our proven expertise in development, synthesis, incl., advanced technologies such as microwave synthesis, and formulation of peptide products. The

Company completed a program in February 2023 for Genentech involving complex macrocyclic peptides. In 2024, a reputed NYSE listed biopharma Company approached us for development of a bispecific small molecule that binds the liver asialoglycoprotein receptor on one hand and the target (IgG) on the other hand joined through a peptide linker. This is an excellent opportunity for us to present our peptide synthesis, small molecule development and manufacturing as well as bioconjugation expertise in the long run. The client will be conducting an audit of the Raichur site at the end of May 2024.

(4) Polymers and performance materials: The global polymers market was valued at USD 597.34 billion in 2022 and is expected to experience robust growth with a projected CAGR of 4.81% through 2028 and is expected to reach at USD 785.80 billion by 2028 (Research and Markets, 2024). Shilpa brings specialized expertise in specialty polymers from custom synthesis through a range of mechanisms, such as free radical polymerization, ring-opening polymerization, anionic and cationic polymerization, ATRP polymerization, RAFT polymerization, and condensation polymerization. We bring specialized expertise in PEGylation chemistry (incl., high MW pegylations), application of poly(butadiene)-b- poly(ethylene oxide) for controlled drug release as well as a range of capabilities in development of derivatives (e.g., functionalization of polybutadienes, and other polymers) and can deliver high quality and cost-effective products at any commercial scale from our USFDA approved facilities. The polymer division has won a number of programs and enjoys long- term relationships with several marquee customers in the polymer space incl., such names as Bausch and Honeywell. The latter began as a modest R&D project that met the specifications defined by client and became a larger initiative which has the potential to become a multi-million dollar program in 2024-2025. Successful deliveries with this Fortune 500 customer also means excellent potential for follow-on as well as new projects.

(5) Antibody-drug conjugates (ADCs): The global antibody drug conjugates market was estimated at USD 11.29 billion in 2023 and is projected to grow at a CAGR of 9.2% from 2024 to 2030 (Grand View Research, 2024). This can be attributed to the growing incidence of cancer, increased need for low-toxicity and effective drugs. An increasing number of ADCs are entering clinical trials and our experience with handling cytotoxic payloads, linker technologies, bioconjugation reactions and antibody development, as well as large in-house manufacturing capacity and the required containment and engineering controls - all under one roof - means we can quickly emerge as a front runner in this space. Given their complexity, more than 70% of ADC projects are outsourced to CDMOs and this is therefore another thrust area for the Company. In 2024, the Company had interest from a marquee NYSE listed biopharma Company to conduct a site audit of the Raichur facilities for potential qualification for development and manufacturing of ADCs. This is a major achievement and an excellent opportunity to break into the ADC market given significant business potential.

(6) Cell and gene therapies: The global cell therapy market size was estimated at USD 4.74 billion in 2023 and is expected to grow at a CAGR of 22.66% from 2024 to 2030. The market for cell therapy is constantly growing to include new cell types, which presents significant opportunities for companies to strengthen their market positions. The growth of the market is attributed to many factors such as expanding area of advanced therapies along with gene delivery technologies and progressive competition among key players focused on commercialization of their therapies. Analysis of companies going public or raising fresh capital indicates nearly 50% of the companies have small- molecule pipelines while 20% are focused on monoclonal antibodies and recombinant proteins and 20% are developing cell and gene therapies. So, while the focus will be on monetizing our existing capabilities and infrastructure in small and large molecules, a future proof strategy will include forward investments into new capabilities, especially in cellular therapies.

(7) Drug Product Development: The Company brings decades of experience developing a wide range of finished dose formulations, e.g., orals, injectables (fill finish in vials and pre-filled syringes), ophthalmics, suspensions, topicals, extended-release formats such as oral thin films and transdermal systems as well as nanoparticle, liposomal and lyophilized preparations. This includes extensive experience in developing value-added clinically differentiated 505(b)(2) products across therapy areas that enhance the patient experience. We have successfully registered >50 products globally incl., in the US and EU markets and bring together synthetic chemistry, process development, manufacturing and regulatory expertise assisted with AI/ML enabled discovery and development for a uniquely integrated CMC approach to drug R&D. The Company has successfully delivered on drug substance and drug product programs under its CDMO business for US based biotech companies following this approach.

SML is extremely well positioned because of these superlative and cross value chain capabilities to become a strong contender for innovative solutioning across modalities to the biopharma, polymer and chemicals industry globally.

Domestic

At Shilpa Medicare Ltd as our key expertise lies in the oncology formulation this Fiscal Year 2023-2024, we have embarked on our journey to reach out to all the cancer treatment facilities nationwide with the primary goal of offering World-Class drugs at competitive pricing, with innovation and affordability to ensure the patient compliance and reduced drug wastage.

By employing the most capable field teams with the best abilities and providing them with the most up-to- date scientific knowledge on treatments and products. In the year 2023-2024, we have expanded our reach to guarantee that the most recent scientific advancements may be disseminated to all Stakeholders, particularly the medical community and caregivers.

At Shilpa Medicare Ltd. (OnKoshil division), patients are at the heart of all we do. With the Mantra of "Thoughtful Innovation for Powerful Outcome," we have produced distinctive Products.

Capebel Dispersible Tablet (Capecitabine 500mg& 1000 mg dispersible tablet) is a great example. Capebel DT enabled clinicians to deliver appropriate doses with more compliance, resulting in a more potent outcome for over 4000 patients in the last Fiscal Year 23-24.

Along with Capebel DT, Lenshil 12mg & 18mg, Oraal Spray and VRTU (Ready to Use pemetrexed Inj) were the classical examples of Shilpa Medicare's approach towards Thoughtful Innovation for Powerful Outcome

Current market trends:

Globally, today India is one of the largest sources of Pharmaceuticals, and Shilpa Medicare Ltd has been one of the strongest API sources for Oncology Products.

In India, an estimated 1.41 million new cancer cases are diagnosed each year with 0.9 million deaths annually, Since the last decade, the cancer burden has more than doubled in India. Breast, Lip, Oral, and Cervical Cancer account for 1/3rd of cancer cases in India. 5-year prevalence is estimated to be around 3.26 million Patients. A recent survey entitled INDIA as the Cancer Capital gives us more responsibility to develop the products and serve the needy.

The domestic oncology market is valued at C7212 Cr and growing at a 21% rate across the range of medicines including hematology and solid tumors. Immunotherapies and Targeted MABs are therapeutic oncology subspecialties that are expanding quickly. Additionally, the new molecular pipeline into the domestic market offers doctors additional possibilities for interventional therapy and new paths for patients needing treatment assistance.

Oncology has a high demand for therapies, making improved formulation with a patient-centric approach even more critical. Shilpa Medicare Ltd is therefore obligated to offer such Thoughtful Innovations for Powerful Outcomes. Strategic Brand Launches into various therapies with futuristic potential and untouched areas. ONKOSHIL is entering the new therapeutical area of Targeted therapies.

Ca Prostate therapy - Launched Leuprolide 22.5mg and Relugolix 120mg in treating Cancer of the Prostate, developing a strong portfolio in the therapy.

Breast Cancer- Ready to launch OLAPARIB, a well- accepted PARPi in the treatment of Breast and Ovarian Cancers - Targeted Therapy.

Supportive Therapy: Iron replacement products like Ferric Carboxy Maltose, and erythropoietin stimulating agent like Darbepoetin.

- Ready to use a 10-minute infusion of Pemetrexed for the first time globally, with unique formulations of 100mg, 500mg 850mg, and 1000mg.

To effectively maximize the benefits of Thoughtful Innovations for Powerful Outcomes, frequent communication aids and performing RTM and CME with doctors and emerging experts are required to effectively reach this communication with the caregivers, and our field force is fully equipped on this front.

Product Reach to the Customers: Product Inclusions into the Formulations of major institutions, which multiply the consumption and provide spread of the brands. Few of the centers where the products are approved.

TATA Memorial Cancer Hospital, KMSCL(Kerala), RAILWAY Hospitals, Command Hospitals, Safdarjung Hospitals (Delhi).

Strategic Growth Factors:

The growth for the next Fiscal is protected with the inclusion of the differentiative formulations into the institutional formulary helps in product awarding and continuous business outcomes,

Unique formulations can have the advantage of monopoly in the formulary and can serve the needs of the needy with the provided advantage of reducing the drug wastage and improving compliance etc.

Registering & making products available at various corporate hospitals to enhance the business & reach across the country. Key account management (customers) and ensure patient follow-up to develop the base.

Recent Trends including pricing in Oncology and Approach:

In the oncology market, new molecules are introduced quickly due to patent expirations. Prices are extremely volatile because of the constant introductions of the same molecules by different companies, but special dosage forms & like Capecitabine DT must be developed with the patient in mind. Decreasing medicine wastage by developing Multidose Ready to Use [RTU] formulations, especially injectables like VRTU.

Effectively communicating the same with regular communication aids and engagements with doctors and emerging specialists is the key to improving the reach of innovations to needy humans.

Strong Growth in Biologic & Biosimilars Drugs in Domestic Market:

The Indian biopharmaceutical industry is one of the fastest growing globally and currently valued at US $60 billion. The country's biosimilars market size was valued at US $349 million (C 2800 Cr) in 2022 and is estimated to expand at a CAGR of 25.2% from 2022 to 2030 to reach US $2.1 billion (C17500 Cr) in 2030.

There are 98 approved biosimilars in India, with at least 50 on the market, the most of any country in the world. Between now and 2030, biologic products worth some $170 billion will lose patent protection, opening the window of opportunity for Indian biopharma to explore more biosimilar products.

With plethora of opportunities, Shilpa with its very own entity Shilpa Biologics Pvt. Ltd, Dharwad has indigenously manufactured and introduced the Original OriAdali (Adalimumab 40mg/0.4ml concentration) in FY 23-24. Shilpa Biosciences - OriAdali is similar to the reference product in quality, safety & efficacy. Indian adalimumab market is valued at C122 Cr market with CAGR 26% (Source: IQVIA) and with launch in just 6 months we have achieved 1% market share.

Shilpa Biosciences, division of SBPL has a vision to reach & serve comprehensive basket for management of Rheumatoid Arthritis (RA) Osteoporosis (OP), Osteoarthritis (OsA) Inflammatory bowel disease (IBD) & Psoriatic Arthritis (PsA).

Shilpa Biosciences has also launch of Denosumab (Denosta) & Teriperatide (Bone PTH) for Osteoporosis management which has further enhanced our presence in the biologics - biosimilar market. Osteoporosis market valued at H466 Cr with CAGR 43%. We have captured 1.30% MS in 1st year of launch. Shilpa Biosciences, at SBPL presence is being felt in market and we have been taken as one of the serious biologic-biosimilar player wherein we have to compete with biologic giants.

Shilpa Biosciences at SBPL, is currently operating in H 693 Cr biologics market with CAGR 34%. IN FY 23-24 we have achieved 1.15% MS of our represented market. Our vision is to attain 7% of MS in first three years of launch.

We have a goal to become one stop solution for the comprehensive management of Rheumatoid Arthritis & Osteoporosis in times to come. We at Shilpa Biosciences at SBPL aim to spread our reach and become one of the strong biologic-biosimilar player in the market.

Shilpa Biologicals Pvt Ltd Introduction

Shilpa Biologicals Pvt Ltd (SBPL) specializes in the development of biologics and has prioritized obtaining approvals and market authorizations for internal projects while expanding its CDMO capabilities. The Company's relentless focus on quality control and assurance underscores its dedication to meeting regulatory standards and delivering superior products and services to its clients and partners.

Biosimilar Programs

SBPL's biosimilar programs for Adalimumab, Aflibercept, Abatacept, Pembrolizumab and Nivolumab, have made significant progress towards global regulatory filing. The strategic focus on obtaining approvals from different markets underscores SBPL's commitment to expanding its global reach and addressing the needs of patients across diverse regions.

Oriadali? Launch:

The SBPL's has launched biosimilar to Humira, Oriadali?, in India during the 1st quarter of 2023-2024 marks a significant milestone for the organization. SBPL's Adalimumab is distinguished as one of the very few biosimilar versions of the innovator's high-concentration product (100mg/mL), offering a cost-effective alternative without compromising quality or efficacy.

Expanding the use of Oriadali? for different indications represents a strategic opportunity for SBPL to further capitalize on its investment in biologics development. By leveraging Oriadali?'s proven efficacy and safety profile, SBPL can explore additional therapeutic areas where anti- TNFa therapy is indicated.

By pursuing regulatory approvals for Oriadali? in these additional indications, SBPL can maximize the commercial potential of its biosimilar while contributing to improved patient outcomes across a diverse range of medical conditions. Furthermore, expanding Oriadali?'s indication portfolio aligns with SBPL's commitment to innovation and addressing unmet medical needs, further solidifying its position as a key player in the biopharmaceutical industry.

Clinical Trials and Pipeline Expansion:

SBPL is currently taking clinical trial batches of biosimilar to Eylea and planning to initiate the phase III clinical trial in Q2 of FY25, demonstrating its commitment to innovation and patient care in ophthalmology. Additionally, the Company has expanded its pipeline with additional three pipeline drugs which are at different developmental stages, from process optimization to preclinical studies, showcasing SBPL's dedication to research and development.

CDMO Capabilities and Strategic Expansion:

SBPL has strategically expanded its operations to offer comprehensive Contract Development and Manufacturing Organization (CDMO) services to pharmaceutical and biotechnology companies worldwide. SBPL's CDMO division leverages the Company's extensive expertise in biologics development, manufacturing, and quality assurance to provide end-to-end solutions tailored to meet the diverse needs of its clients.

Comprehensive Service Offerings:

SBPL's CDMO capabilities encompass a wide range of services spanning the entire drug development and manufacturing lifecycle. These include:

1. Process Development: SBPL's team of experienced scientists and engineers collaborate closely with clients to develop robust and scalable manufacturing processes tailored to their specific requirements. From cell line development to process optimization and scale-up, SBPL offers comprehensive process development services to accelerate the path to commercialization.

2. Analytical Method Development and Validation:

SBPL's state-of-the-art analytical laboratories are equipped with advanced instrumentation and expertise to develop and validate analytical methods for product characterization, quality control, and stability testing. By ensuring the accuracy, precision, and reliability of analytical data, SBPL enables clients to meet regulatory requirements and ensure product quality.

3. Manufacturing: SBPL operates cGMP-compliant manufacturing facilities equipped with cutting-edge bioprocessing technologies to produce biologics at various scales. Whether it's microbial fermentation, mammalian cell culture, or downstream purification, SBPL's manufacturing capabilities are designed to deliver high-quality, cost-effective solutions to meet client demand.

4. Quality Assurance and Regulatory Compliance:

SBPL places a strong emphasis on quality control and assurance throughout its CDMO operations. Its quality management system is aligned with international regulatory standards, ensuring compliance with Good Manufacturing Practices (GMP) and other regulatory requirements. SBPL's dedicated quality assurance team monitors all stages of the manufacturing process to ensure product quality, safety, and efficacy.

Strategic Partnerships and Collaborations:

SBPL actively seeks strategic partnerships and collaborations with pharmaceutical and biotechnology companies to leverage its CDMO capabilities and expand its market presence. By offering flexible and customized solutions, SBPL aims to address the evolving needs of its clients and provide value-added services that contribute to their success.

Recent Achievements and Future Outlook:

In the current year, SBPL's CDMO division has witnessed remarkable growth and achievement, marked by the expansion of its client base and service portfolio. Through successful project executions and unwavering dedication to quality and innovation, SBPL has emerged as a trusted partner in the global biopharmaceutical landscape. With a commitment to excellence, SBPL continues to lead the industry, offering tailored solutions to meet the evolving needs of clients both domestically and internationally.

Regulatory Approvals and Inspections:

SBPL achieved joint inspections and clearance from the Central Drugs Standard Control Organization (CDSCO) for marketing authorization of its Biosimilar to Humira and Bioanalytical Laboratory. These achievements not only facilitate clinical trial programs but also open new avenues for revenue generation through contract research organization (CRO) activities.

Positive Scientific Advice from the FDA & EMA:

SBPL is pleased to announce that we have received positive feedback from the FDA and EMA regarding our CMC package and clinical trial proposals for Aflibercept. This validation from regulatory experts reinforces the robustness and efficacy of our development strategies, positioning us for success in obtaining regulatory approvals for the biosimilar products in the regulatory market. Building on the positive feedback received from the EMA, SBPL remains focused on advancing the development of Aflibercept while maintaining the highest standards of quality and compliance.

Conclusion:

In conclusion, the achievements of Shilpa Biologicals Pvt Ltd in the fiscal year 2023-2024 underscore its position as a leader in the biopharmaceutical sector. Through strategic initiatives, relentless focus on quality, and dedication

to innovation, SBPL is poised for sustained growth and success in the years to come.

FTF PHARMA (P) LTD

The journey started in 2012 for FTF Pharma has been ‘unstoppable' and continued to leave its footprints worldwide. FTF Pharma is not a new name in the pharmaceutical world. It has achieved a special ‘reputation' milestone over these years, which is evident from the fact that yearly it adds many new clients to its clientele list.

When a dream was seen to become a CDO/CDMO of every partner's choice, the Company was started with very limited resources, infrastructure and manpower. However, steadfastly moving towards its mission, in very short span FTF Pharma grew to a level where it now owns a 55,000 sq. ft. state-of-the-art R&D center with modern & well equipped formulation & analytical research labs and facility for handling highly potent drugs situated in the hub of India's Pharmaceutical giants, Ahmedabad (Gujarat). Over 70 scientists are striving day and night to help FTF Pharma achieve its mission of becoming globally leading player in the Contract Research sector. FTF is a one stop solution for its partners. FTF offers Research and Formulation Development services, Technology Transfer & Contract Manufacturing services, Non-infringing/ Design-around strategies, Regulatory filing strategies, and BA/BE & clinical support services.

Visioned to provide the best and most affordable healthcare, FTF is focused on the development of high valuedfirst-to-file generic products underANDAregulatory pathway, complex generic products & innovative new drug products covered by 505b2 NDA applications. FTF eyes its interest on the development of small molecule drug products & peptide drug products as well as repurposing of existing drugs. Since its inception, FTF, so far, has developed & collaborated more than 120 products for major regulated markets & rest of the world markets.

FTF has an expertise of developing different types of solid, liquid, lyophilized & topical dosage forms. These dosage forms include tablets, hard gel capsules, low & high volume parenterals (ready-to-use/dilute solutions, suspensions), lyophilized solids, oral thin films, strips, patches, prefilled syringes, ophthalmic solution & drops, coated/uncoated/sugar coated/film coated pellets/beads in capsules, matrix dosage forms, orally disintegrating tablets, IR/ER/PR/SR/DR/MR dosage forms, bi-layered tablets, and combination products. So far, coming age technologies in the pharmaceutical development are concerned, FTF is not lacking behind. FTF is also working on new-edge technologies such as Nano-emulsions, SMEDDS, micellar formulations and lipid nanoparticles.

Success is not a ‘dream' for FTF Pharma but a reality. The drug products developed by FTF Pharma are now approved by the world's some of the major regulated markets such as US and UK. These products include first to file generics of Aubagio?, Opsumit? and Otezla?; 505b2 oral liquids such as Norliqva? (amlodipine oral solution), Tadliq? (tadalafil oral suspension), Zonisade? (zonisamide oral suspension), Liqrev? (sildenafil oral suspension), Atorvaliq? (atorvastatin oral suspension), Myhibbin? (mycophenolate mofetil oral suspension) and oral solution of Imatinib mesylate; and a ready-to- use Pemetrexed injection against Alimta? powder for reconstitution under 505b2 NDA approval pathway. These products are now in the market and have met the needs and benefited thousands of patients.

FTF's approach towards drug development through innovation is evident from its Intellectual Property filings. FTF has filed more than 110 patent applications in different jurisdictions including USA, Europe/UK, Canada, China, and India and awarded multiple US & Indian patents covering FTF's 505b2 oral & parenteral technologies.

It's been about 4 years now that FTF has been spearheaded by Shilpa Medicare Limited Group (SML) and achieved new milestones by penetrating the US, Europe, Canada, China and other emerging markets. Now it can be foreseen that FTF is not away from its vision of becoming one of the TOP GLOBAL CROs by 2025.

Shilpa Therapeutics Pvt. Ltd (formerly NU Therapeutics Pvt. Ltd.)

Situated at Cherlapally, IDA Phase-III, Medchal-Malkajgiri District, Hyderabad, Telangana, India - 500051, a progressive novel drug delivery Company with an international outlook is dedicated to the development and commercialization of innovative and patient compliant novel drug delivery systems such as fast disintegrating oral strips.

*Shilpa Therapeutics Pvt. Ltd.(formerlyNUTherapeutics Pvt. Ltd.) is the first Company to commercialize prescription products as oral thin strips/films in India.

The plant has recently Upgraded to carter Regulated Markets like ROW and European countries and the products are being updated to cater the registration requirements of the respective countries.

• Products available in the Domestic Market

Shilpa Therapeutics had obtained manufacturing and marketing license from the Drugs Control General (India), New Delhi for the following products and these products have also been launched in India by well-established national pharmaceutical companies.

• Products in the Pipeline

The following formulations are under various stages of Research & Product Development along with several others in the initiation phase.

• Strong Intellectual Property Management Team /Profile

Shilpa Therapeutics (formerly NU Therapeutics) has a strong IP profile. The Company has been granted several patents on orally disintegrating strips

A state-of-the-art R&D center for developing oral strips and sublingual film products, works in co-ordination with the Intellectual Property Management team to develop cost effective generics and novel patentable formulations.

Patent filing statistics:

Total Filed : 35

Total Granted : 5

STPL to continue aggressive patent filings and protection of IP in India and other important geographies of the world and plan to monetize the same.

STPL will continue to build its future pipeline of innovative and "first-time-in-the-world" fast dissolving films with Intellectual Property (IP) advantages and we are confident that the overall result of our initiatives will be evident in the coming years.

• Regulatory Approvals

ShilpaTherapeuticsPvt Ltd (formerlyNUTherapeutics) has received approval for its oral disintegrating strip facility from following regulatory authorities:

• National Pharmaceutical Regulatory Agency (NPRA) Malaysia, which is an PIC/S member (Pharmaceutical Inspection Co- operation Scheme)

• Ministry of Health Thailand'

• Tanzania Medicines and Medical Devices

• Pharmacy Poison Board - Kenya

• National Drug Authority - Uganda

• Regulatory Authority of DR Congo

• Supreme Board Of Yemen

• Regulatory Authority Cambodia

Many of the products are under screening process in above Ministries of Health and are in verge of the products approval.

STANDALONE AND CONSOLIDATED FINANCIAL STATEMENTS:

The Standalone and Consolidated Financial Statements of your Company have been prepared in accordance with Indian Accounting Standards (‘Ind AS') notified under the Companies (Indian Accounting Standards) Rules, 2015, as amended.

Further, a statement containing the salient features of the Financial Statements of our subsidiaries pursuant to subsection 3 of Section 129 of the Companies Act, 2013 in the prescribed form AOC-1 is appended as Annexure to the Board's Report. The Statement also provides the details of performance and financial position of each of the subsidiaries.

SUBSIDIARIES, ASSOCIATES & JOINT VENTURES

The Company has direct and step down subsidiaries in India and overseas. Consolidated financial statements have been prepared by the Company in accordance with the requirements of Ind AS 27 issued by Institute of Chartered Accountants of India (ICAI) and as per the provisions of the Companies Act, 2013 ("the Act").

As per the provisions of Section 136 of the Act, separate audited financial statements of subsidiaries are placed by the Company on its website at www.vbshilpa.com. Statement containing the salient features of the financial statement of subsidiaries and associate Company for the year ending March 31, 2023 in Form AOC-1

CHANGE IN THE NATURE OF BUSINESS

During the year under review, there was no change in the nature of business carried out by your Company.

RAISING OF FUNDS THROUGH QUALIFIED INSTITUTIONAL PLACEMENT:

The Board of Directors of the Company at its meeting held on February 08, 2024 approved raising of funds for an amount not exceeding H 500 Crores through Qualified Institutional Placement route. The Shareholders' of the Company passed Special Resolution by way of postal ballot on 14th March 2024 to approve the raising of funds through QIP.

The Company submitted Preliminary Placement Documents and Placement Document to National Stock Exchange of India Limited and BSE Limited ("Stock Exchanges") on 8th April 2024. Subsequent to which receipt of In-Principle approval from the Stock Exchanges on 8th April 2024, the Board of Directors at its meeting held on April 13, 2024 approved the issue and allotment of 1,09,89,010 Equity Shares of face value T1 each to eligible qualified institutional buyers at the issue price of T455 per Equity Share, i.e., at a premium of T454 per Equity Share (which includes a discount of T22.33 per Equity Share (4.68% of the floor price) to the floor price of T477.33 per Equity Share, aggregating to T 4,99,99,99,550 (Rupees Four Hundred and Ninety Nine Crores Ninety Nine Lakhs Ninety Nine Thousand Five Hundred Fifty only).. Consequently, the Promoter Shareholding in the Company stands decreased from 50.01% to 44.39% whereas the Public shareholding increased from 49.99% to 55.61% w.e.f. April 13, 2024 .

DIVIDEND:

In pursuance to the Dividend Distribution policy of the Company, your Directors do not recommend any dividend for the year. The Dividend Distribution Policy of the Company is set out as Annexure-2 and the same is uploaded on the Company's website at https:// www.vbshilpa.com/pdf/Dividend%20Distribution%20PolicyUpdate.pdf

SHARE CAPITAL:

The paid up share capital of your Company is H 9,77,90,908/- (Rupees Nine Crore Seventy Seven Lakhs Ninety Thousand Nine hundred and Eight) divided into 9,77,90,908 equity shares of H 1/- each.

Pursuant to the provisions of section 124 (5) of the Companies Act, 2013 read with the IEPF Rules, the Company has transferred 8214 shares, belonging to the shareholders who did not continuously claim dividend for seven years from the financial year 2016- 17 to IEPF Account, the details of which are placed on the website of the Company.

LISTING OF EQUITY SHARES:

The securities of the Company are listed on National Stock Exchange of India Limited (NSE) and BSE Limited (BSE). Further, the Company has no equity shares carrying differential rights.

TRANSFER TO RESERVES:

During the financial year under review, your Company has not transferred any amount to the general reserve.

DIRECTORS OR KEY MANAGERIAL PERSONNEL:

Mr. Omprakash Inani (DIN No.01301385), Non-Executive Director will retire by rotation at the ensuing Annual General Meeting and being eligible, offers himself for re-appointment.

CHANGE IN DIRECTORSHIP

During the year there were no changes in the Directorship.

Mr. Hetal Madhukant Gandhi & Mr. Arvind Vasudeva were appointed as Independent Directors for a period of 3 yrs in the 34th AGM held on 28th September 2021, effective upto the conclusion of the AGM to be held in 2024.

Members in the 32nd AGM held on 20th September 2019 reappointed Mr. Vishnukant C Bhutada as Managing Director for a period of 5 years effective from 1st October 2019. In 2022, Mr. Bhutada was also appointed as Managing Director of Shilpa Pharma Lifesciences Ltd, a material subsidiary on a remuneration of H 3.50cr as minimum remuneration in case of inadequacy of profits from Shilpa Medicare Ltd and remuneration in excess of 5% on the net profits of Shilpa Pharma Lifesciences Ltd, with an overall remuneration not exceeding H 15.00cr p.a for reminder of the tenure.

Since tenure of the Directors is due for completion, except Mr. Arvind Vasudeva who did not express his willingness to continue, their reappointment sought is subject to the approval of members of the Company at the ensuing Annual General Meeting.

CHANGE IN KEY MANAGERIAL PERSONNEL

There were no changes in the Key Managerial Personnel during the year. Following are the key managerial personnel of the Company:

Mr. Vishnukant C Bhutada - Managing Director

Mr. Kalakota Sharath Reddy - Whole-time Director

Mr. Alpesh M Dalal - Chief Financial Officer

Mrs. Ritu Tiwary - Company Secretary & Complian ce Off icer

NUMBER OF MEETINGS OF THE BOARD:

During the financial year, Seven Board Meetings were held as detailed below which are in compliance with the provisions of the Companies Act, 2013, the Listing Regulations and Secretarial Standards on Board meeting:

1. 25 May 2023

2. 23 June 2023

3. 21 July 2023

4. 10 August 2023

5. 1 September 2023

6. 10 November 2023

7. 8 February 2024

STATEMENT OF DECLARATION GIVEN BY INDEPENDENT DIRECTORS UNDER SUB- SECTION (6) OF SECTION 149:

The Independent Directors have submitted their declaration of Independence, as required under Section 149(7) of the Companies Act, 2013 stating that they meet the criteria of independence as provided in Section 149(6) and Regulation 25 of SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015.

Statutory Auditors:

Members of the Company at the Annual General Meeting held on 28 September 2022 approved the appointment of M/s. Bohara Bhandari Bung And Associates LLP, Chartered Accountants, Raichur FRN:008127S/S200013, as the new statutory auditors of the Company to hold office for one term of 5 years commencing from conclusion of the ensuing 35th Annual General Meeting up to the 40th Annual General Meeting of the Company.

Cost Auditors:

The Board, on the recommendation of the Audit Committee, has appointed M/s. V.J. Talati & Co., Cost Accountants, for conducting the audit of cost records of various segments of the Company for the financial year 2024-25. As required under Section 148 of the Companies Act, 2013 and Rule 14 of the Companies (Audit and Auditors) Rules, 2014, a resolution is being placed at the ensuing Annual General Meeting for ratification of remuneration payable to the said Cost Auditors.

Secretarial Auditors:

Mr. D.S. Rao, Practicing Company Secretary was appointed to conduct the Secretarial Audit of the Company for the financial year 2023-24, as required under Section 204 of the Companies Act, 2013 and Rule 9 framed thereunder. The Secretarial Audit Report, in form MR-3, for the financial year 2023-24 forms part of this Report as Annexure - 3.

The Board on the recommendation of the Audit Committee has appointed Mr. D S Rao, Practicing Company Secretaries, as Secretarial Auditors of the Company for the financial year 2024-25.

Internal Auditor:

Pursuant to the provisions of section 138 of the Companies Act, 2013 and rules made thereunder, the Board on the recommendation of the Audit Committee has appointed M/s BDO India LLP as Internal Auditors of the Company for the financial year 2024-25.

Statutory Auditors:

As there is no qualification, reservation or adverse remark in the reports given by the Statutory Auditors, your directors need not provide any clarification on the same.

Secretarial Auditors:

As there is no qualification, reservation or adverse remark in the reports given by the Secretarial Auditors, your directors need not provide any clarification on the same.

CONSERVATION OF ENERGY, TECHNOLOGY ABSORPTION, FOREIGN EXCHANGE OUTGO:

Information required under section 134(3)(m) of the Companies Act, 2013 read with Rule 8 of the Companies (Accounts) Rules, 2014, is enclosed herewith as Annexure - 4

RISK MANAGEMENT POLICY:

Pursuant to Regulation 21(4) of SEBI (LODR) Regulations, 2015, the Board of Directors have formulated and implemented a Risk Management Policy, which identifies various elements of risks, which, in its opinion, may threaten the existence of the Company and contains measures to mitigate the same. The Risk Management Policy of the Company is hosted on the Company's website: www.vbshilpa.com.

A Risk Management Committee has been constituted as per the terms of Regulation 21 of SEBI (LODR) Regulations, 2015 to monitor and review the major risks faced by and the risk management plan of the Company periodically.

During the year two Risk Management Committee meetings were held on 16 September 2023 & 13 March 2024.

CORPORATE SOCIAL RESPONSIBILITY (CSR) POLICY:

In terms of the provisions of Section 135 read with Schedule VII to the Companies Act, 2013 and the Companies (Corporate Social Responsibility Policy) Rules, 2014, a Corporate Social Responsibility Policy (CSR Policy), indicating the activities to be undertaken by the Company, as framed by the Corporate Social Responsibility Committee (CSR Committee) has been adopted by the Board of Directors. Accordingly, the Company has transferred the CSR amount to ‘Shilpa Foundation', a public charitable trust taking up various social public causes of the society in and around Raichur, Karnataka and the activities of the said trust are covered under the Schedule VII of the Companies Act, 2013. A report on the CSR activities, as required under Rule 8 of the Companies (Corporate Social Responsibility) Rules, 2014, is enclosed herewith as Annexure - 5.

The Company has constituted the CSR Committee for monitoring the activities undertaken by the Company in this regard. The CSR Policy of the Company and other details as required is are placed on the Company's website at https://www.vbshilpa.com/pdf/Nomination RemunerationPolicy.pdf

A Committee of the Board named as "Nomination and Remuneration Committee" has been constituted to comply with the provisions of Section 178, Schedule IV of the Companies Act and Regulation 19 of SEBI (LODR) Regulations, 2015. It has been entrusted with the task to recommend to the Company the prospective Directors and KMP who possess the requisite skills and positive attributes as specified in the Nomination and Remuneration Policy.

The Nomination and Remuneration Committee has formulated a Nomination and Remuneration Policy which recommends the guidelines based on which the annual performance of the Independent Directors, Board and Individual Directors is carried out by the Board.

The Nomination and Remuneration Policy of the Company is placed on the Company's website at https://www.vbshilpa.com/pdf/NominationRemunerationPolicy.pdf

FORMAL ANNUAL EVALUATION MADE BY THE BOARD OF ITS OWN PERFORMANCE AND OF ITS COMMITTEES AND INDIVIDUAL DIRECTORS:

The Board of Directors have carried out an annual evaluation of its own performance, as well as that of its Committees and individual directors pursuant to the provisions of the Sections 134 and 178 read with Schedule IV to the Companies Act, 2013. A structured questionnaire was prepared after taking into consideration inputs received from the Directors, covering various aspects of the Board's functioning such as adequacy of the composition of the Board and its Committees, execution and performance of specific duties by the Board of Directors, independence governance, ethics and values, attendance and contribution at meetings etc.

The performances of the Independent Directors were evaluated by the Board after seeking inputs from all the directors on the effectiveness and contribution of the Independent Directors.

The performance of the Committees was evaluated by the Board after seeking inputs from the Committee members based on the criteria such as the composition of Committees, effectiveness of Committee Meetings, etc.

The Board reviewed the performance of the individual directors on the basis of criteria such as the contribution of the individual director to the Board and Committee Meetings, like preparedness on the issues to be discussed, meaningful and constructive contribution and inputs in Meetings, etc. In addition, the Chairman was also evaluated on the key aspects of his role.

In a separate meeting of Independent Directors, performance of the Non-Independent Directors, performance of the Board as a whole and performance of the Chairman was evaluated, taking into account the views of Executive Directors and Non- Executive Directors. The Independent Directors also assessed the quality, quantity and timeliness of flow of information between the Board and the management that is necessary for the Board to perform its functions reasonably and effectively. The same was discussed in the Board Meeting that followed the meeting of the Independent Directors.

FINANCIAL STATEMENTS:

In accordance with the provisions of Section 129 (3) of the Companies Act, 2013, the Standalone and Consolidated Financial Statements, drawn up in accordance with the applicable Accounting Standards, form part of this Annual Report.

In accordance with Rule 8 (1) of Companies (Accounts) Rules 2014, the highlights of performance of the Subsidiaries, Associates and Joint Ventures and their contribution to the overall performance of the Company have been detailed in Annexure - 1 enclosed to this report.

Further, the annual accounts of all the subsidiary companies are available on the Company's website www.vbshilpa.com

Annual accounts of the Subsidiary Companies and related detailed information will be available for inspection by the members, at the registered office of the Company and will also be made available to the members upon request.

ADEQUACY OF INTERNAL FINANCIAL CONTROLS WITH REFERENCE TO THE FINANCIAL STATEMENTS:

The Company has Internal Control Systems, commensurate with the size, scale and complexity of its operations. Various Audit systems in the Company monitor and evaluate the efficacy and adequacy of the internal control systems of the Company, its compliance with operating systems, accounting procedures and policies at all locations of the Company. Based on the audit reports, the concerned department/ unit undertakes corrective action in the respective areas and strengthens the controls. Significant audit observations and corrective actions thereon are presented to the Audit Committee of the Board periodically.

The Board of Directors of the Company have adopted various policies like Related Party Transactions Policy, Whistle Blower Policy, Policy to determine Material Subsidiaries, Code of Conduct for Regulating, Monitoring and Reporting Insider Trading and such other procedures for ensuring orderly and efficient conduct of its business for safeguarding its assets, prevention and detection of frauds and errors, accuracy and completeness of the accounting records and timely preparation of reliable financial information.

DETAILS OF THE COMPANIES WHICH HAVE BECOME OR CEASED TO BE SUBSIDIARIES, JOINT VENTURES OR ASSOCIATE COMPANIES DURING THE YEAR UNDER REVIEW:

The following instances took place during the year under review which need to be reported in accordance with Rule 8(5) (iv) of Companies (Accounts) Rules, 2014:

During the year, apart from Pilnova Pharma Inc, a subsidiary in USA there are no new Companies that have become Subsidiaries/Joint ventures/ Associate Companies of Shilpa Medicare Limited.

Your Company has filed a Second Stage petition with National Company Law Tribunal for effecting the amalgamation with INM Technologies Private Limited being the wholly owned subsidiary, The Company is awaiting for the final order of the Hon'ble tribunal in this regard.

Your Company has filed a Second Stage petition with National Company Law Tribunal for effecting the amalgamation with Shilpa Therapeutics Private Limited being the wholly owned subsidiary, The Company is awaiting for the final order of the Hon'ble tribunal in this regard.

DIRECTORS' RESPONSIBILITY STATEMENT:

Pursuant to Section 134 (5) of the Companies Act, 2013 Your Directors' confirm that:

Applicable accounting standards have been followed in the preparation of the annual accounts and that no material departures have been made from the same;

Accounting policies have been selected and applied consistently. Judgments and estimates made are reasonable and prudent, so as to give a true and fair view of the state of affairs of the Company at the end of the FY2023 and of the profit of the Company for that period;

Proper and sufficient care has been taken to maintain adequate accounting records in accordance with the provisions of the Act for safeguarding the assets of the Company and for preventing and detecting fraud and other irregularities;

Annual accounts have been prepared on a going concern basis

Adequate internal financial controls for the Company to follow have been laid down and these are operating effectively; and

Proper and adequate systems have been devised to ensure compliance with the provisions of all applicable laws and these systems are operating effectively

EXTRACT OF ANNUAL RETURN:

In accordance with Section 92(3) of the Act and rule 12(1) of the Companies (Management and Administration) Rules, 2014 (as amended), a copy of the Annual Return of the Company has been placed on the Website of the Company at www.vbshilpa.com

Committees of Board:

Your Company has the following committees, namely: Audit Committee

Nomination and Remuneration Committee Stakeholders Relationship Committee Corporate Social Responsibility Committee Risk Management Committee

The constitutions of all the committees are as per the provisions of the Companies Act, 2013 and SEBI (LODR) Regulations, 2015. The details of the constitution are mentioned in Corporate Governance Report, which forms part of this Annual Report.

CORPORATE GOVERNANCE REPORT:

Regulation 15 of SEBI (LODR) Regulations, 2015 is applicable to your Company and as such the details as specified in Schedule V(C) of SEBI (LODR) Regulations, 2015, with regard to Corporate Governance Report including Practicing Company Secretary's Certificate on compliance with the conditions of Corporate Governance specified in Schedule V(E) of SEBI (LODR) Regulations, 2015 as well as a certificate as specified in Schedule V(C) (10)(i) of SEBI (LODR) 2015 forms part of the Annual report as Annexure- 6.

MANAGEMENT DISCUSSION AND ANALYSIS:

The Management Discussion and Analysis Report for the year under review as stipulated under Regulation 34 read with Schedule V (B) to the SEBI (LODR) Regulations, 2015 is annexed hereto and forms part of this Annual Report.

VIGIL MECHANISM:

In pursuance to the provisions of Section 177(9) & (10) of the Companies Act, 2013 and Regulation 22 of SEBI (LODR) Regulations, 2015, a vigil mechanism for directors and employees to report genuine concerns has been established. The Policy on vigil mechanism i.e. Whistle Blower Policy may be accessed on the Company's website at https://www.vbshilpa.com. The policy provides for a framework and process for safeguard against victimization of director(s) or employee(s) or any other person who avail the mechanism and allow direct access

to the Chairman of the Audit Committee in exceptional cases. Your Company adheres to uncompromising integrity in conduct of its business and strictly abides by well-accepted norms of ethical, lawful and moral conduct. It has zero tolerance for any form of unethical conduct or behaviour. Directors and employees are at liberty to report unethical practices.

REMUNERATION RATIO OF THE DIRECTORS/ KEY MANAGERIAL PERSONNEL/EMPLOYEES:

Statement showing disclosures pertaining to remuneration and other details as required under Section 197(12) of the Companies Act, 2013 read with Rule 5(1) of the Companies (Appointment and Remuneration of Managerial Personnel) Rules, 2014 is enclosed herewith as Annexure-7.

PARTICULARS OF EMPLOYEES:

Statement of employees as required under Rule 5(2) of the Companies (Appointment and Remuneration of Managerial Personnel) Rules, 2014, is enclosed as Annexure - 8 to the Board's Report.

COST RECORDS AND COST ACCOUNTS:

The Company is maintaining cost records and accounts as specified by the Central Government under subsection (1) of section 148 of the Companies Act, 2013.

DISCLOSURE UNDER SEXUAL HARASSMENT OF WOMEN AT WORKPLACE (PREVENTION, PROHIBITION, AND REDRESSAL) ACT, 2013:

Your Company has always provided a safe and harassment free workplace to every individual working in its premises through various policies and practices. Your Company always endeavors to create an environment that is free from discrimination and harassment, including sexual harassment. Your Company has been actively involved in ensuring that the clients and all the employees are aware of the provisions of the POSH Act, 2013 and the rights available to them there under.

Your Company has in place an Anti-Sexual Harassment Policy in line with the requirements of the Sexual Harassment of Women at workplace (Prevention, Prohibition and Redressal) Act, 2013. Internal Complaints Committee has been set up to redress the complaints received regarding sexual harassment. Your Company did not receive any complaints during the period under review.

PARTICULARS OF LOANS, GUARANTEES OR INVESTMENTS:

Details of the loans granted, guarantees given, securities provided and investments made during the year under review, as covered under Section 186 of the Companies Act, 2013, are detailed in the notes to the financial statements which may be read as a part of this Report.

DEPOSITS:

During the year under review, your Company has not accepted any deposits within the meaning of Section 73 of the Companies Act, 2013 read with the Companies (Acceptance of Deposits) Rules, 2014.

RELATED PARTY TRANSACTIONS:

Related Party Transactions entered into during the financial year under review are disclosed in Note No. 45 to the Financial Statements. These transactions were at an arm's length basis and in the ordinary course of business. There were no materially significant Related Party Transactions with the Company's promoters, directors, management or their relatives which could have had a potential conflict with the interests of the Company. Form AOC-2, containing a note on the aforesaid Related Party Transactions is enclosed herewith as Annexure - 9.

Related Party disclosures as per Schedule V of SEBI (LODR) Regulations, 2015 are enclosed herewith as Annexure - 10.

The policy on Related Party Transactions, as approved by the Board may be accessed on the Company's website https://www.vbshilpa.com/pdf/related party policy.pdf.

BUSINESS RESPONSIBILITY & SUSTAINABILITY REPORT:

The SEBI vide its circular dated 10 May 2021 made Business Responsibility & Sustainability (BRSR) Mandatory for top 1000 Listed Companies (by Market Capitalization) from the FY 2023, while disclosure was voluntary for the FY 2022.

Pursuant to Clause 34(2)(f) of the SEBI (LODR) Regulations, 2015 Business Responsibility & Sustainability Report, being applicable to the Company, forms part of the Board Report as Annexure - 11.

GENERAL:

Your Directors state that no disclosure or reporting is required in respect of the following items as there were no transactions on these items during the year under review:

Issue of equity shares with differential rights as to dividend, voting or otherwise. Issue of shares (including sweat equity shares) to employees of the Company under any scheme.

Neither the Managing Director nor the Whole-time Director of the Company received any remuneration or commission from any of its subsidiaries.

No significant or material orders were passed by the Regulators or Courts or Tribunals which impact the going concern status and Company's operations in future.

No frauds were reported by the auditors during the year under review.

There are no material changes and commitments affecting the financial position of the Company occurred between the end of the financial year to which the financial statements relate and the date of the report.

No applications were filed before or any proceedings pending under the Insolvency and Bankruptcy Code, 2016

The details of Difference between valuation done at the time of one time settlement and the valuation done while taking loan from the banks and financial institutions along with the reason thereof - Not Applicable.

The Company has complied with Secretarial Standards, i.e. SS-1, and SS-2 relating to Meetings of the Board of Directors and General Meetings respectively, issued by the Institute of Company Secretaries of India and notified by the Ministry of Corporate Affairs.

Your Directors wish to express their gratitude to the Central and State Governments, investors, analysts, financial institutions, banks, business associates and customers, the medical profession, distributors and suppliers for their whole- hearted support. Further, Your Directors would like to express the appreciation to all the employees of your Company for their continued dedication, significant contributions, hard work and commitment towards achieving the objects of the Company.