Drug firm Glenmark today said it has received US health regulator's approval to sell generic Clotrimazole cream, used in treating fungal infections, in the American market.
Glenmark Generics Inc, a US-based subsidiary of the company has received Abbreviated New Drug Application (ANDA) approval from US Food and Drug Administration (USFDA) for Clotrimazole cream USP 1 per cent, Glenmark Pharmaceuticals said in a statement.
"The company will commence marketing and distribution of this product in the US market immediately," it added.
According to research firm IMS Health, Clotrimazole cream has achieved annual sales of $ 26 million in US for the fiscal ended March this year.
The product is the generic version of Taro's Clotrimazole Cream USP and will be manufactured at the company's facility in Goa.
Clotrimazole is the 16th topical semi solid product which the company would market in the US. It is an anti-fungal cream indicated for the treatment for candidiasis and tinea versicolor, a skin condition charecterised by rash on the trunk.
Glenmark's current portfolio consists of 59 products which have been cleared by USFDA for US market. The company has further 50 ANDA's pending approval with the US health regulator.
Shares of Glenmark were today trading at Rs 267.95 on Bombay Stock Exchange, up 1 per cent from its previous close.
