Glenmark Generics Inc., USA (GGI), a subsidiary of Glenmark Pharmaceutical, has received final ANDA approval from US FDA for norethindrone acetate 5mg tablets and will commence marketing and distribution of the product immediately.
Norethindrone acetate is the generic version of Duramed Research, Inc.’s Aygestin and is indicated for the treatment of secondary amenorrhea, endometriosis, and abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology, such as submucous fibroids or uterine cancer. According to IMS Health, norethindrone acetate tablets garnered approximately USD 27 million in sales for the 12 month period ending March 2010.
Today’s approval marks the second product approval by the US FDA from Glenmark’s state-of-the-art hormone facility located in Goa, India. Glenmark continues to build an extensive pipeline in this arena with a specialized portfolio in various stages of development, from early R&D to pending ANDA’s with the US FDA. The US contraceptive market has historically been the largest of the seven major markets with sales reaching USD 4.5 billion in the 12 month period ending December 2009 (MIDAS sales data, IMS Health).
Glenmark’s current portfolio consists of 57 products authorized for distribution in the US market. The company has over 50 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, a developing EU presence and Argentina and maintains marketing front-ends in these countries. It primarily sells its FDF products in the United States and the European Union, as well as its oncology FDF products in South America. The company supplies APIs to customers in approximately 63 countries, including the US, various countries in the EU, South America and India.
Glenmark Generics Limited is proposing, subject to market conditions and other considerations, a public issue of its equity shares and has filed a Draft Red Herring Prospectus with SEBI.