Glenmark Generics Limited (GGL) has received ANDA approval from the United States Food and Drug Administration (US FDA) for Alclometasone dipropionate ointment, 0.05% and will commence marketing and distribution of this product in the US market immediately. In June'09, Glenmark received FDA approval for Alclometasone dipropionate cream.
Today's approval compliments Glenmark's recent launch of Alclometasone dipropionate cream and allows the company to provide superior service to their customers by offering the complete line of Alclometasone topical products. Generic competition on these niche products are limited.
Alclometasone dipropionate ointment is a low to medium potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Glenmark's product is the AB rated generic equivalent of GSK's Aclovate ointment.
Glenmark's version of both the cream and ointment will be manufactured in its US FDA approved, state of the art semi-solid facility located in Baddi, India. The company is now authorized to market 12 topical semi-solids in the United States.
Glenmark's current portfolio consists of over 40 products authorized for distribution in the US marketplace. The company has over 40 ANDA's pending for 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 and portfolio.