Glenmark Pharmaceuticals Inc., USA (Glenmark) has received US FDA approval for potassium chloride extended-release capsules USP, 10 mEq, the therapeutic equivalent to the reference listed drug product, potassium chloride extended-release capsules USP, 10 mEq, of Actavis Laboratories FL, Inc. Further the company also received approval for norethindrone acetate and ethinyl estradiol tablets USP, 1 mg/0.02 mg, the generic version of Loestrin 21 1/20 tablets of Warner Chilcott Company, LLC.
According to IMS Health sales data for the 12 month period ending November 2015, the potassium chloride extended-release capsules, 10 mEq market achieved annual sales of approximately $74.1 million. Similarly, the Loestrin 211/20 tablets market achieved annual sales of approximately $56.8 million..
Glenmark’s current portfolio consists of 106 products authorized for distribution in the US marketplace and 63 ANDA’s pending approval with the US 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.