Granules gets FDA nod for anxiety disorder drug
image for illustrative purpose
Hyderabad: City-based pharmaceutical major, Granules India Limited on Friday announced that the US Food and 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. This medication is indicated for the treatment of - Major Depressive Disorder (MDD), Generalised Anxiety Disorder (GAD), Social Anxiety Disorder (SAD) and Panic Disorder (PD).
Venlafaxine is bioequivalent to the reference listed drug product (RLD), Effexor XR Extended-Release Capsules of Upjohn US 2 LLC. The current annual US market for Venlafaxine ER Capsules is approximately $153 million, according to MAT Mar 2023, IQVIA/IMS Health.
The pharma company now has a total of 56 ANDA approvals from US FDA (54 final approvals and two tentative approvals).
Granules is present in the manufacturing of entire value chain – from Active Pharmaceutical Ingredients, Pharmaceutical Formulation Intermediates , and Finished Dosages.
