Glenmark Pharmaceuticals gets USFDA tentative approval for Topiramate Extended Release Capsules

Glenmark Pharmaceuticals has been granted tentative approval by the United States Food & Drug Administration (U.S. FDA) for Topiramate Extended‐Release Capsules, 25 mg, 50 mg, 100 mg, 150 mg, and 200 mg, a generic version of QUDEXY1 XR Extended‐Release Capsules, 25 mg, 50 mg, 100 mg, 150 mg, and 200 mg, of Upsher‐ Smith Laboratories, LLC.

Glenmark's current portfolio consists of 148 products authorized for distribution in the U.S. marketplace and 54 ANDA's pending approval with the U.S. FDA. In addition to these internal filings, Glenmark continues to identify and explore external development partnerships to supplement and accelerate the growth of its existing pipeline and portfolio.

Powered by Capital Market - Live News