Granules India’s wholly-owned foreign subsidiary -- Granules Pharmaceuticals, Inc. (GPI) has received Abbreviated New Drug Application (ANDA) approval from US Food & Drug Administration (USFDA) for Bupropion Hydrochloride Extended-Release Tablets USP (XL), 150 mg and 300 mg. It is bioequivalent to the reference listed drug product, Wellbutrin XL Extended-Release Tablets, 150 mg and 300 mg, of Bausch Health US, LLC.
Bupropion Hydrochloride is used as an antidepressant medication used to treat major depressive disorder (MDD) and seasonal affective disorder (SAD). Granules now have a total of 50 ANDA approvals from USFDA (48 Final approvals and 2 tentative approvals).
The current annual U.S. market for Bupropion Hydrochloride Extended-Release Tablets USP (XL), 150 mg and 300 mg is approximately $661 million.
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).
