Granules India has received approval from the US Food & Drug Administration (USFDA) for 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 HCI 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.
Granules India is manufacturer and supplier of pharmaceutical products. Its products include active pharmaceutical ingredients (API) like tablets, caplets, rapid release, pharmaceutical, formulation intermediates (PFI) and Finished Dosages (FDs).
