Granules India has received an approval from the U.S. Food & Drug Administration (USFDA) for 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 USFDA.
Granules India is manufacturer and supplier of pharmaceutical products. Its products include active pharmaceutical ingredients (API) like tablets, caplets, rapid release, pharmaceutical, formulation intermediates (PFI) and Finished Dosages (FDs).
