Glenmark Generics Inc., USA, the subsidiary of Glenmark Generics Ltd has received final ANDA approval from the US FDA for clotrimazole cream USP, 1 per cent and will commence marketing and distribution of this product in the US market immediately.
Clotrimazole is indicated for the topical treatment of candidiasis due to candida albicans and tinea versicolor due to malassezia furfur and achieved annual sales of US$ 26 million for the 12 months ending March 2010, as per IMS Health report.
Glenmark's product is the AB rated therapeutic equivalent of Taro's clotrimazole cream USP and will be manufactured at Glenmark's US FDA approved semi-solid facility located in Goa, India.
Clotrimazole is the 16th topical semi-solid product Glenmark is authorized to market in the US. This approval aligns with Glenmark's strategy to continue building upon their established presence in the dermatology marketplace.
Glenmark's current portfolio consists of 59 products authorized for distribution in the US marketplace. The company has close to 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.