Glenmark Generics Inc. USA, a subsidiary of Glenmark Generics, has received final abbreviated new drug approval (ANDA) from the US FDA for norethindrone acetate and ethinyl estradiol tablets USP, 0.5 mg/2.5 mcg and 1 mg/5 mcg. Glenmark will commence distribution of the product immediately.

Norethindrone acetate and ethinyl estradiol tablets USP, 0.5 mg/2.5 mcg and 1 mg/5 mcg are Glenmark’s generic version of Warner Chilcott’s FemHRT. These tablets are indicated for the treatment of moderate to severe vasomotor symptoms due to menopause and for the prevention of postmenopausal osteoporosis in women at significant risk of osteoporosis. For the 12 month period ending February 2015, the FemHRT market garnered annual sales of USD 38.6 million according to IMS Health.

Glenmark’s current portfolio consists of 96 products authorized for distribution in the US marketplace and 69 ANDA’s pending approval with the US FDA. In addition to these internal filings, GGI continues to identify and explore external development partnerships to supplement and accelerate the growth of the existing pipeline and portfolio.

GGL has an established presence in North America and developing an EU presence. It primarily sells its FDF products in the US and the EU, as well as its oncology FDF products in South America. The company supplies APIs to customers in approximately 80 countries, including the US, various countries in the EU, South America and India.

The Hon’ble Bombay High Court passed an order approving the amalgamation of Glenmark Generics with Glenmark Pharmaceuticals and these companies are currently in the process of complying with further directions of the said order.