Glenmark Pharmaceuticals Inc., USA (Glenmark) has received final approval by the US FDA for Hailey Fe 1/20 (norethindrone acetate and ethinyl estradiol tablets USP, 1 mg/20 mcg and ferrous fumarate tablets), the generic version of Loestrin Fe 1/20 tablets, of Allergan Pharmaceuticals International Ltd.
According to IQVIA sales data for the 12 month period ending September 2017, the Loestrin Fe 1/20 tablets market achieved annual sales of approximately $116.8 million.
Glenmark’s current portfolio consists of 129 products authorized for distribution in the US marketplace and 58 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.
Glenmark has several molecules in various stages of clinical development and is focused in the areas of oncology, dermatology and respiratory. The company has significant presence in the branded generics markets across emerging economies including India. Glenmark has 16 manufacturing facilities across five countries and has six R&D centers. The generics business of Glenmark services the requirements of the US and Western European markets. The API business sells its products in over 80 countries, including the US, various countries in the EU, South America and India.