Granules Pharmaceuticals, Inc., a wholly-owned foreign subsidiary of Granules India, has achieved a significant milestone by securing approval from the U.S. Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) of Bupropion hydrochloride extended-release tablets USP (SR).

The approved tablets are bioequivalent and therapeutically equivalent to GlaxoSmithKline LLC’s Wellbutrin SR sustained-release tablets, available in 100 mg, 150 mg, and 200 mg dosages.

Bupropion hydrochloride extended-release tablets are widely prescribed for the treatment of major depressive disorder and for the prevention of seasonal affective disorder..

With this latest approval, Granules India has achieved a total of 67 ANDA approvals from the US FDA, reflecting its commitment to expanding its footprint in regulated markets.

Dr. Krishna Prasad Chigurupati, Chairman and Managing Director of Granules India, commented, “This ANDA approval marks a significant milestone in our journey to expand Granules’ presence in the U.S. market. Our continued focus on expanding our product portfolio in regulated markets like the U.S. ensures that we are meeting the growing healthcare needs of patients globally while maintaining the highest standards of safety and efficacy.”

Granules India is primarily engaged in manufacturing and selling Active Pharmaceutical Ingredients (APIs), Pharmaceutical Formulation Intermediates (PFIs), and Finished Dosages (FDs).

The company has reported strong financial performance, with a consolidated net profit of ₹134.65 crore in Q1 FY25, a substantial increase from ₹47.89 crore in Q1 FY24. Revenue from operations for the same quarter reached ₹1,179.87 crore, reflecting a 19.72% growth from ₹985.52 crore a year earlier.

Following the announcement, Granules India’s shares  ended 0.11% higher at ₹595.10 apiece on the Bombay Stock Exchange.