USFDA18 Oct 2024, 05:51 pm
Granules India Receives USFDA Approval for Bupropion Hydrochloride Extended-Release Tablets
AI Summary
Granules India Limited announced 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. This approval marks a significant milestone for the company, expanding its presence in the U.S. market and meeting the growing healthcare needs of patients globally. The company now has a total of 67 ANDA approvals from the US FDA.
Key Highlights
- Granules India Limited receives USFDA approval for Bupropion Hydrochloride Extended-Release Tablets USP (SR) 100 mg, 150 mg, and 200 mg.
- This approval marks a significant milestone for the company, expanding its presence in the U.S. market.
- Granules Pharmaceuticals, Inc., a wholly owned foreign subsidiary of the Company, filed the ANDA.
- Bupropion Hydrochloride Extended-Release Tablets USP (SR) are bioequivalent and therapeutically equivalent to Wellbutrin SR Sustained-Release Tablets by GlaxoSmithKline LLC.
- Granules India Limited now has a total of 67 ANDA approvals from the US FDA.