Granules India bags USFDA nod for Venlafaxine Hydrochloride ER Capsules
Venlafaxine HCl extended-release capsules are indicated for the treatment of Major Depressive Disorder, Generalized Anxiety Disorder, Social Anxiety Disorder and Panic Disorder.
Hyderabad: Drugmaker, 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.
Read also: USFDA nod to Granules India postherpetic neuralgia drug Gabapentin
Medical Dialogues team had earlier reported that the USFDA had approved the Abbreviated New Drug Application (ANDA) filed by Granules Pharmaceuticals, Inc (GPI) for Bupropion Hydrochloride Extended-Release Tablets USP (XL), 150 mg and 300 mg.
Read also: USFDA okays Granules Pharma Bupropion Hydrochloride ER Tablets
Granules India Limited, incorporated in 1991 is a vertically integrated Indian pharmaceutical company headquartered at Hyderabad. Granules is among the few pharmaceutical companies in the world to be present in the manufacturing of entire value chain – from Active Pharmaceutical Ingredients (APIs), Pharmaceutical Formulation Intermediates (PFIs), and Finished Dosages (FDs). Its 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 UK. The Company has 7 manufacturing facilities out of which 6 are in India and 1 in the USA and has regulatory approvals from US FDA, EDQM, EU GMP, COFEPRIS, WHO GMP, TGA, K FDA, DEA, MCC, and HALAL.
