Granules India Secures USFDA Nod for Bupropion SR Tablets

20 Oct 2024 , 07:33 PM

Granules Pharmaceuticals, Inc., a subsidiary of Granules India, has received USFDA approval for its Abbreviated New Drug Application (ANDA) of Bupropion hydrochloride extended-release tablets USP (SR).

The approved tablets are bioequivalent to GlaxoSmithKline LLC’s Wellbutrin SR and are available in 100 mg, 150 mg, and 200 mg dosages. Bupropion hydrochloride is widely prescribed for treating major depressive disorder (MDD) and preventing seasonal affective disorder (SAD).

This approval adds to Granules India’s existing 67 ANDA approvals from the US FDA, strengthening its position in regulated markets.

Dr. Krishna Prasad Chigurupati, Chairman and Managing Director of Granules India, highlighted the milestone, emphasizing the company’s dedication to expanding its product portfolio in the U.S. while maintaining safety and efficacy.

Granules India focuses on manufacturing and selling Active Pharmaceutical Ingredients (APIs), Pharmaceutical Formulation Intermediates (PFIs), and Finished Dosages (FDs).

The company reported impressive financial results in Q1 FY25, with a consolidated net profit of ₹134.65 Crore, a sharp rise from ₹47.89 Crore in Q1 FY24. Revenue for Q1 FY25 reached ₹1,179.87 Crore, marking a 19.72% growth from ₹985.52 Crore in Q1 FY24.