Granules India Limited announced today that the US Food & Drug Administration (US FDA) has approved its Abbreviated New Drug Application (ANDA) for Venlafaxine Hydrochloride Extended-Release Capsules USP, 37.5 mg, 75 mg, and 150 mg. It is bioequivalent to the reference listed drug product (RLD), Effexor XR Extended-Release Capsules of Upjohn US 2 LLC.
Venlafaxine HCl extended-release capsules are indicated for the treatment of: Major Depressive Disorder (MDD), Generalized Anxiety Disorder (GAD), Social Anxiety Disorder (SAD) and Panic Disorder (PD).
Granules now have a total of 56 ANDA approvals from US FDA (54 Final approvals and 2 tentative approvals).
The current annual U.S. market for Venlafaxine ER Capsules is approximately $153 Million, according to MAT Mar 2023, IQVIA/IMS Health.
Shares of Granules India Limited was last trading in BSE at Rs. 277.65 as compared to the previous close of Rs. 286.10. The total number of shares traded during the day was 146291 in over 3882 trades.
The stock hit an intraday high of Rs. 289.80 and intraday low of 276.40. The net turnover during the day was Rs. 41208094.00.