Granules gets USFDA nod for antidepressant drug

Hyderabad: Hyderabad-based Granules India said the US Food & Drug Administration (US FDA) has approved the Abbreviated New Drug Application (ANDA) filed by Granules Pharmaceuticals, Inc (GPI), a wholly owned foreign subsidiary of the company, for Bupropion Hydrochloride Extended-Release Tablets USP (XL), 150 mg and 300 mg. It is bioequivalent to the reference listed drug […]

Hyderabad: Hyderabad-based Granules India said the US Food & Drug Administration (US FDA) has approved the Abbreviated New Drug Application (ANDA) filed by Granules Pharmaceuticals, Inc (GPI), a wholly owned foreign subsidiary of the company, for Bupropion Hydrochloride Extended-Release Tablets USP (XL), 150 mg and 300 mg.

It is bioequivalent to the reference listed drug product, Wellbutrin XL Extended-Release Tablets, 150 mg, and 300 mg, of Bausch Health US, LLC. Bupropion Hydrochloride is used as an antidepressant medication to treat major depressive disorder and seasonal affective disorder.

Commenting on the approval Priyanka Chigurupati, ED, GPI, said “This product will be a valuable addition to our growing modified release product portfolio in the US market. The approval stands as a testimonial for our research and project management competence.”
Granules now have a total of 50 ANDA approvals from US FDA (48 Final approvals and 2 tentative approvals).

The current annual US market for Bupropion Hydrochloride Extended-Release Tablets USP (XL), 150 mg and 300 mg are approximately $661 million, according to MAT Dec 2021, IQVIA/IMS Health.

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