Glenmark Pharmaceuticals (Glenmark), a manufacturer of generic formulation products and API has been granted final approval by the United States Food & Drug Administration (U.S. FDA) for Desmopressin Acetate Tablets, 0.1 mg and 0.2 mg, the therapeutic equivalent of DDAVP, 0.1 mg and 0.2 mg, of Ferring Pharmaceuticals, Inc. Glenmark plans to commence shipping of Desmopressin Acetate Tablets immediately.
According to IMS Health sales data for the 12 month period ending March 2015, the DDAVP market achieved annual sales of approximately USD 72.1 million.
Glenmark's current portfolio consists of 97 products authorized for distribution in the U.S. marketplace and 68 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.
Shares of the company gained Rs 5.65, or 0.66%, to trade at Rs 862.95. The total volume of shares traded was 21,429 at the BSE (9.57 a.m., Friday).