Hyderabad, January 8, 2026, Granules India Limited (NSE: GRANULES, BSE: 532482) announced that its wholly owned US subsidiary has received tentative approval with 180-day exclusivity for generic amphetamine extended-release tablets, marking a significant step in expanding its central nervous system product pipeline in the United States.
Key Development and Market Opportunity
The tentative approval covers amphetamine extended-release tablets in strengths of 5 mg, 10 mg, 15 mg, and 20 mg, the generic equivalent of a leading branded ADHD therapy. The product is indicated for the treatment of Attention Deficit Hyperactivity Disorder and addresses an estimated US market opportunity of approximately USD 41 million.The 180-day exclusivity eligibility enhances the commercial attractiveness of the product and is expected to support differentiated entry upon final approval and launch.
Momentum in Complex Generics
This milestone follows another tentative approval received in late December 2025 for amphetamine extended-release orally disintegrating tablets across multiple strengths, also indicated for ADHD. That product operates in a relatively concentrated competitive landscape, with a limited number of approved and authorized generics, and an addressable market estimated at USD 172 million. Together, these back-to-back approvals underscore the company’s execution capabilities in complex and differentiated formulations.Management Commentary
Commenting on the development, Dr. Krishna Prasad Chigurupati, Chairman and Managing Director, said the exclusivity-linked approval validates the company’s long-term strategy of building a differentiated portfolio of complex generics. He added that the development reinforces Granules’ focus on expanding its presence in the CNS therapeutic space while enhancing value creation in the US generics market.About the Company
Granules India Limited is a vertically integrated pharmaceutical company headquartered in Hyderabad, with operations spanning active pharmaceutical ingredients, pharmaceutical formulation intermediates, finished dosages, and peptide CDMO services. Incorporated in 1991, the company supplies products to more than 300 customers across regulated and semi-regulated markets, with a global footprint covering over 80 countries. Its manufacturing network includes facilities in India, the United States, and Switzerland, supporting a broad and diversified product portfolio.Source:
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