Granules Pharmaceuticals, Inc., a 100% foreign subsidiary of Granules India received the U.S. Food & Drug Administration (USFDA) approval for abbreviated new drug application (ANDA) of Bupropion hydrochloride extended-release tablets USP (SR).
Bupropion hydrochloride extended-release tablets USP (SR) is bioequivalent and therapeutically equivalent to wellbutrin SR sustained-release tablets, 100 mg, 150 mg, and 200 mg, by GlaxoSmithKline LLC.The approved ANDA is a widely prescribed medication for the treatment of major depressive disorder and for the prevention of seasonal affective disorder.
The group now has a total of 67 ANDA approvals from the US FDA.
Dr. Krishna Prasad Chigurupati, chairman and managing director, Granules India, said, "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 involved in the manufacturing and selling of Active Pharmaceutical Ingredients (APIs), Pharmaceutical Formulation intermediates (PFIs) and Finished Dosages (FDs).
The pharma company reported a consolidated net profit of Rs 134.65 crore in Q1 FY25, steeply higher than Rs 47.89 crore posted in Q1 FY24. Revenue from operations in first quarter of FY25 was at Rs 1,179.87 crore, up 19.72% from Rs 985.52 crore reported in the same period a year ago.
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Shares of Granules India shed 0.19% to Rs 592.15 on the BSE.
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