Glenmark receives 2 ANDA approvals from the FDA

Glenmark receives ANDA approvals for Potassium Chloride Extended-Release Capsules USP, 10 mEq and Norethindrone Acetate and Ethinyl Estradiol Tablets USP, 1 mg/0.02 mg

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Glenmark’s current portfolio consists of 106 products authorized for distribution in the US marketplace

Glenmark Pharmaceuticals USA (Glenmark) has been granted final approval by the United States Food and Drug Administration (US FDA) for Potassium Chloride Extended-Release Capsules USP, 10 mEq. The drug is therapeutic equivalent to the reference listed drug product, Potassium Chloride Extended-Release Capsules USP, 10 mEq, of Actavis Laboratories.

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.

Glenmark has also been granted final approval by US FDA 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.

According to IMS Health sales data for the 12 month period ending November 2015, the Loestrin 21 1/20 Tablets market1 achieved annual sales of approximately $56.8 million.

 

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