Glenmark Generics Limited (GGL) has received ANDA approval from the US FDA for Ciclopirox Olamine cream, 0.77 per cent and will commence marketing and distribution of this product in the US market.
Ciclopirox Olamine cream generated sales of approximately USD 8 million as per IMS report in the 12 month period ending September 2009 and is the generic equivalent of Loprox cream marketed by Medicis. This broad-spectrum antifungal is indicated for the topical treatment of the dermatological infections tinea pedis, tinea cruris, tinea corporis, candidiasis (moniliasis) and tinea (pityriasis) vesicolor.
Today’s approval augments the breadth of Glenmark’s semi-solid line, increasing their overall dermatological portfolio to 13 products. In addition, the company has a significant number of ANDA applications pending approval from the US FDA and continues to validate their objective towards building a strong presence in this niche segment.
Glenmark is currently authorized to distribute 50 products, translating to over 175 sku’s, in the US marketplace and has 46 ANDA’s pending approval with the US FDA. Along with a strategic focus dedicated to internal filings, GGI continues to identify and explore external development partnerships to supplement and accelerate the growth of the existing pipeline and portfolio.