Granules India Limited announced on Friday that the U.S. Food & Drug Administration (USFDA) has approved the Abbreviated New Drug Application (ANDA) for Bupropion Hydrochloride Extended-Release Tablets USP (SR) 100 mg, 150 mg, and 200 mg filed by Granules Pharmaceuticals, Inc. (GPI), a wholly owned foreign subsidiary of the Company.
Bupropion Hydrochloride Extended-Release Tablets USP (SR) are bioequivalent and therapeutically equivalent to Wellbutrin SR Sustained-Release Tablets, 100 mg, 150 mg, and 200 mg, by GlaxoSmithKline LLC.
This is a widely prescribed medication for the treatment of major depressive disorder and for the prevention of seasonal affective disorder. Granules now has a total of 67 ANDA approvals from the US FDA.
“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,” Dr. Krishna Prasad Chigurupati, Chairman and Managing Director, Granules India Limited, said.
