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Granules India Limited Received ANDA Approval for Venlafaxine ER Capsules

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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.

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