Glenmark Pharmaceuticals receives ANDA tentative approval for Nintedanib Capsules, 100 mg and 150 mg

Glenmark Pharmaceuticals Ltd (Glenmark) has received tentative approval by the United States Food & Drug Administration (U.S. FDA) for Nintedanib Capsules, 100 mg and 150 mg, the generic version of Ofev®1 Capsules, 100 mg and 150 mg, of Boehringer Ingelheim Pharmaceuticals, Inc. According to IQVIA™ sales data for the 12 month period ending […]

Glenmark Pharmaceuticals launches Rufinamide Tablets USP, 200 mg and 400 mg

Glenmark Pharmaceuticals Limited (Glenmark) has launched Rufinamide Tablets USP, 200 mg and 400 mg, a therapeutic equivalent of Banzel® Tablets, 200 mg and 400 mg of Eisai, Inc. Glenmark was one of the first ANDA applicants to submit a substantially complete ANDA for Rufinamide Tablets USP, 200 mg and 400 mg, with a paragraph IV certification and […]