Mumbai, Dec. 22 -- Granules Pharmaceuticals Inc., a wholly owned subsidiary of Granules India, has received Tentative Approval (TA) 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(R). It will be manufactured at Granules' US-based facility located in Chantilly, Virginia.

Published by HT Digital Content Services with permission from Capital Market....