Cadila Healthcare’s wholly owned subsidiary -- Zydus Pharmaceuticals (USA) has received the final approval from the United States Food & Drug Administration (USFDA) to market Minocycline Hydrochloride Extended-Release Tablets in strengths of 45 mg, 80 mg, 90 mg, 105 mg, and 135 mg. Zydus also received the tentative approval for Minocycline Hydrochloride Extended-Release Tablets, 55 mg, 65 mg, and 115 mg.
Minocycline Hydrochloride Extended-Release Tablets are a tetracycline-class drug, indicated to treat only inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 12 years of age and older. It will be produced at the group's formulations manufacturing facility at Moraiya, Ahmedabad.
The group now has more than 170 approvals and has so far filed over 310 ANDAs since the commencement of the filing process in FY 2003-04.
Zydus Cadila is an innovative, global pharmaceutical company that discovers, develops, manufactures and markets a broad range of healthcare therapies.
