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The latest announcement is out from Granules India Limited ( (IN:GRANULES) ).
Granules Pharmaceuticals Inc., the US-based wholly owned subsidiary of Granules India Limited, has received tentative approval from the US Food and Drug Administration for its abbreviated new drug application for generic amphetamine extended-release orally disintegrating tablets, a substitute for ADZENYS XR-ODT, in six dosage strengths to be manufactured at its Chantilly, Virginia facility. The product, indicated for the treatment of ADHD and in a market estimated at around USD 172 million, will enter a space currently served by only one approved generic and one authorised generic, potentially enhancing competition and patient access while reinforcing Granules’ strategic push into complex, differentiated central nervous system therapies and strengthening its US generics portfolio and capabilities in advanced dosage forms and patient-friendly delivery technologies.
More about Granules India Limited
Granules India Limited is a vertically integrated Indian pharmaceutical company, incorporated in 1991 and headquartered in Hyderabad, with operations spanning the full value chain from active pharmaceutical ingredients and pharmaceutical formulation intermediates to finished dosages and peptides CDMO services. The company supplies products to more than 300 customers across over 80 countries, operates 11 manufacturing facilities in India, the US and Switzerland, and holds key regulatory approvals from major global health authorities, underscoring its focus on quality, operational excellence and global generics markets.
Average Trading Volume: 41,040
Technical Sentiment Signal: Strong Buy
Current Market Cap: 141.5B INR
Find detailed analytics on GRANULES stock on TipRanks’ Stock Analysis page.