Granules India received ANDA approval for Venlafaxine ER Capsules

Granules India received ANDA approval for Venlafaxine 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.

FPJ Web DeskUpdated: Friday, May 19, 2023, 09:46 AM IST
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Granules India received ANDA approval for Venlafaxine ER Capsules | Image: Granules India (Representative)

Granules India Limited received US Food & Drug Administration's (US FDA) approval for its Abbreviated New Drug Application (ANDA) for Venlafaxine Hydrochloride Extended-Release Capsules USP, 37.5 mg, 75 mg, and 150 mg, the company announced through an exchange filing. 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.

Granules shares

The shares of Granules on Friday at 9:44 am IST were at Rs 276.75, down by 0.36 per cent.

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