Cenobamate is a next-generation antiseizure medication indicated for the treatment of partial-onset seizures in adults. Clinical studies have demonstrated significant seizure reduction and high seizure freedom rates in patients with inadequately controlled epilepsy, positioning the drug as an important advancement in epilepsy treatment.

Commenting on the development, Anil Jain, managing director of Bajaj Healthcare, said the SEC recommendation marks a significant regulatory milestone and reflects the company's progress in developing Cenobamate tablets. He added that Bajaj Healthcare will continue to work with regulatory authorities to secure the necessary approvals for commercialisation while strengthening its presence in the specialty pharmaceuticals and central nervous system (CNS) therapies segment.

Bajaj Healthcare specializes in manufacturing intermediates, API, formulations & Nutraceuticals. The Company has state-of-art manufacturing facilities of APIs, intermediates and formulations. These facilities are designed to meet the requirements of both advanced as well as emerging market opportunities. BHL has a strong presence globally in countries like Europe, USA, Australia, Middle East and South America.

The company reported a standalone net loss of Rs 22.85 crore in Q4 FY26, compared with a net profit of Rs 11.17 crore posted in Q4 FY25. Revenue from operations shed 0.91% YoY to Rs 153.05 crore in Q4 FY26, compared with Rs 154.47 crore in the corresponding quarter last year.