Granules Pharma receives USFDA tentative approval for amphetamine ER ODT ANDA

Granules Pharma receives USFDA tentative approval for amphetamine ER ODT ANDA

Granules Pharmaceuticals, a wholly owned subsidiary of Granules India, has received Tentative Approval from the United States Food and Drug Administration for its Abbreviated New Drug Application for Amphetamine Extended-Release Orally Disintegrating Tablets. The ANDA covers strengths of 3.1 mg, 6.3 mg, 9.4 mg, 12.5 mg, 15.7 mg and 18.8 mg. The product is the generic equivalent of ADZENYS XR-ODT and will be manufactured at Granules’ US-based fac…

Granules India Receives Tentative USFDA Approval for ADHD Treatment

Granules India Limited announced that its US-based subsidiary, Granules Pharmaceuticals Inc., has received tentative approval from the US Food and Drug Administration (USFDA) for a medication used in the treatment of attention deficit hyperactivity disorder (ADHD). The development has drawn attention to the company’s stock, which closed the previous trading session marginally higher at ₹583.3 per share. Details of the Regulatory Approval The USF…