Glenmark Pharma bags USFDA nod for Topiramate Extended-Release Capsules
Mumbai: Drug major, Glenmark Pharmaceuticals Limited, has recently announced that the company has received final approval by the United States Food & Drug Administration (USFDA) for Topiramate Extended-Release Capsules, 25 mg, 50 mg, 100 mg, 150 mg, and 200 mg.
The product is a generic version of Qudexy XR Capsules, 25 mg, 50 mg, 100 mg, 150 mg, and 200 mg, of Upsher-Smith Laboratories, LLC.
According to IQVIATM sales data for the 12 month period ending December 2020, the Qudexy XR Capsules, 25 mg, 50 mg, 100 mg, 150 mg, and 200 mg market achieved annual sales of approximately $120.8 million*.
Glenmark's current portfolio consists of 169 products authorized for distribution in the U.S. marketplace and 43 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," Glenmark said in a filing.
