Currently, the market has only one approved generic and one authorised generic, giving Granules a favourable position to expand access to this therapy upon launch.

The company said the tentative approval strengthens its US generics portfolio and underscores its continued investments in complex dosage forms, patient-friendly delivery technologies, and value-driven healthcare solutions.

Dr Krishna Prasad Chigurupati, chairman and managing director, stated, “The tentative approval of this ANDA reaffirms Granules’ strategic focus on expanding its portfolio of complex and differentiated generics while strengthening its presence in the central nervous system (CNS) therapeutic area. ADHD is one of the most commonly diagnosed neurodevelopmental disorders in the United States and impacts hundreds of millions of people worldwide. At Granules, we remain committed to improving patient access by delivering high-quality, affordable medications across global markets.”

Granules India is primarily involved in the manufacturing and sale of active pharmaceutical ingredients (APIs), pharmaceutical formulation intermediates (PFIs), and finished dosages (FDs).

The company’s consolidated net profit declined 16.3% to Rs 112.64 crore, while net sales increased 3.4% to Rs 1,208.79 crore in Q2 FY26 compared with Q2 FY25.

The counter rose 0.25% to Rs 584.75 on the BSE.