Glenmark Generics Limited (GGL) has received ANDA approval from the United States Food and Drug Administration for Ciclopirox Olamine Cream, 0.77 % and will commence marketing and distribution of this product in the U.S. market.
Ciclopirox Olamine cream generated sales of approximately USD 8 million* 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 Abbreviated New Drug Applications pending approval from the 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 U.S. marketplace and has 46 ANDA’s pending approval with the U.S. 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.
*Information provided by IMS Health
The Glenmark Pharma stock closed the day at Rs.222.20, down by Rs.0.15 or 0.07%. The stock hit an intraday high of Rs.225 and low of Rs.220.
The total traded quantity was 74016 compared to 2 week average of 242342.
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