Granules Pharma earns USFDA tentative nod for Attention Deficit Hyperactivity Disorder drug
Written By : Ruchika Sharma
Medically Reviewed By : Dr. Kamal Kant Kohli
Published On 2025-12-22 05:51 GMT | Update On 2025-12-22 05:53 GMT
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Hyderabad: Granules Pharmaceuticals, a wholly owned subsidiary of Granules India, has received tentative approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Amphetamine Extended-Release Orally Disintegrating Tablets in strengths of 3.1 mg, 6.3 mg, 9.4 mg, 12.5 mg, 15.7 mg, and 18.8 mg, the generic equivalent of ADZENYS XR-ODT.
It will be manufactured at Granules’ US-based facility located in Chantilly, Virginia.
It's products are being distributed to over 300+ customers in regulated and semi-regulated markets with a global presence extending to over 80+ countries with offices across India, US and Switzerland. The Company has 11 manufacturing facilities out of which 8 are in India, 2 in the USA and 1 in Switzerland and has regulatory approvals from US FDA, EDQM, EU GMP, COFEPRIS, WHO GMP, TGA, K FDA, DEA, MCC, and HALAL.
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