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Granules India Limited ( (IN:GRANULES) ) has issued an announcement.
Granules Pharmaceuticals, Inc., the U.S. subsidiary of Granules India Limited, has received tentative approval from the U.S. FDA for its Abbreviated New Drug Application for generic amphetamine extended-release tablets, the equivalent of Dyanavel XR, in multiple strengths, along with eligibility for 180-day marketing exclusivity in the U.S. ADHD market valued at about $41 million. This follows a recent tentative FDA nod for its generic version of Adzenys XR-ODT, targeting a significantly larger ADHD market segment of around $172 million, underscoring the group’s strengthening capabilities in complex generics, bolstering its CNS portfolio, and enhancing its competitive positioning and value creation potential in the U.S. generics space.
More about Granules India Limited
Granules India Limited is a Hyderabad-based pharmaceutical company operating through its wholly owned U.S. subsidiary, Granules Pharmaceuticals, Inc., focusing on the development and commercialization of complex and differentiated generic medicines for regulated markets, with a growing presence in central nervous system (CNS) therapies.
Average Trading Volume: 42,805
Technical Sentiment Signal: Buy
Current Market Cap: 146.8B INR
For detailed information about GRANULES stock, go to TipRanks’ Stock Analysis page.