Granules India Secures USFDA Approval for Antidepressant Medication

Granules India received approval from the USFDA for a generic antidepressant, Bupropion Hydrochloride extended-release tablets. The company, through its subsidiary GPI, can market the drug, bioequivalent to Wellbutrin SR, in various strengths. This approval expands Granules India's footprint in the US market.

Granules India has achieved a significant milestone with the USFDA's approval to market a generic medication aimed at treating major depressive disorder, as reported on Friday.

The Hyderabad-based pharmaceutical company announced the approval of its Bupropion Hydrochloride extended-release tablets by the US Food & Drug Administration. These tablets, in strengths of 100 mg, 150 mg, and 200 mg, will now be available to the US market.

This approval allows Granules India, through its subsidiary Granules Pharmaceuticals, Inc., to offer a bioequivalent version of GlaxoSmithKline's Wellbutrin SR tablets. Chairman and Managing Director Krishna Prasad Chigurupati highlighted this as a step forward in meeting global healthcare needs.

(With inputs from agencies.)