Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted final approval by the United States Food & Drug Administration (U.S. FDA) for Azelaic Acid Gel, 15%, a generic version of Finacea Gel, 15%, of Leo Pharma A/S.

According to IQVIATM sales data for the 12 month period ending September 2018, the Finacea Gel, 15% market2 achieved annual sales of approximately USD 64.1 million.

Glenmark's current portfolio consists of 143 products authorized for distribution in the U.S. marketplace and 56 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 declined Rs 4.4, or 0.68%, to trade at Rs 641.95. The total volume of shares traded was 3,845 at the BSE (9.23 a.m., Tuesday).