Granules India stock gains on USFDA nod for ADHD drug

Granules India shares rose over 1% on Thursday after the pharma firm announced it has received tentative approval from the US Food and Drug Administration (USFDA) for its Amphetamine Extended-Release Orally Disintegrating Tablets in strengths of 3.1mg, 6.3mg, 9.4mg, 12.5mg, 15.7mg, and 18.8mg. This product is the generic equivalent of ADZENYS XR-ODT and is indicated for the treatment of attention deficit hyperactivity disorder (ADHD).

Granules India shares stock rose 1.25% to Rs 621 against the previous close of Rs 612.45 on BSE. Market cap of the firm stood at Rs 15,044 crore. Later, the stock closed 1.43% lower at Rs 603.70.

The company highlighted the product's estimated US market size of approximately $41 million and noted that only one other approved generic and one authorised generic exist, with an addressable market share cited at $172 million. Granules India is eligible for 180-day exclusivity, providing a critical window to capture additional market share upon launch.

This is seen as a significant milestone in its strategy to build a differentiated portfolio of complex generics. Krishna Prasad Chigurupati, chairman and managing director, said, "Having a product that is eligible for 180-day exclusivity, Granules strongly validates our long-term strategy of building a differentiated portfolio of complex generics."

Over the past twelve months, the stock has remained broadly flat, indicating subdued investor sentiment despite the regulatory news. The product's tentative approval adds to Granules India's pipeline, which continues to compete against other established players in the generics sector. Specific competitor names were not disclosed in the regulatory filing.

The 180-day exclusivity on the newly approved ADHD drug is expected to strengthen Granules India's positioning in the US generics market. The company's focus on complex formulations aligns with broader trends favouring differentiated product portfolios that reduce direct competition and optimise margins.