Strides Arcolab received ANDA approval from the United States Food & Drug Administration (US FDA) for its imiquimod cream, which according to IMS data, has a market of approximately US$ 140 million in the US. This is the first product approval from beltapharm, the Company’s US FDA approved semi solids facility in Milan, Italy.
The product will be launched immediately and will be marketed directly by Strides in the US market. Imiquimod cream is a topical skin cream indicated for the treatment of certain types of actinic keratoses (precancerous skin lesions) on the face or scalp, and external genital and perianal warts in patients 12 years and older.
Headquartered in Bangalore, Strides Arcolab, develops and manufactures a wide range of IP-led niche pharma products and has its presence in over 75 countries in both developed and emerging markets.