Granules India has announced that the U S Food & Drug Administration (USFDA) has granted approval for its Abbreviated New Drug Application (ANDA) for Bupropion Hydrochloride Extended-Release Tablets USP (SR) in strengths of 100 mg, 150 mg, and 200 mg. The ANDA was filed by Granules Pharmaceuticals, Inc. (GPI), a wholly owned subsidiary of Granules India.
Bupropion Hydrochloride Extended-Release Tablets are bioequivalent and therapeutically equivalent to Wellbutrin SR Sustained-Release Tablets, a popular medication produced by GlaxoSmithKline LLC. This drug is widely prescribed for the treatment of major depressive disorder (MDD) and for the prevention of seasonal affective disorder (SAD).
With this latest approval, Granules India has secured a total of 67 ANDA approvals from the USFDA, further strengthening its presence in the U.S. market.
Commenting on the approval, Dr Krishna Prasad Chigurupati, Chairman and Managing Director of 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 aims to enhance its product offerings in international markets, aligning with its goal of delivering high-quality, affordable healthcare solutions.
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