Glenmark Generics (GGL) has received ANDA approval from the FDA for Ciclopirox Olamine cream, 0.77 % and will commence marketing and distribution of the product in the US market.
The antifungal cream is indicated for the topical treatment of the dermatological infections tinea pedis, tinea cruris, tinea corporis, candidiasis(moniliasis) and tinea(pityriasis) vesicolor.
The 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.
Glenmark is currently authorised to distribute 50 products, translating to over 175 SKU’s, in the US marketplace and has 46 ANDA’s pending approval with the 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.