Alembic Pharmaceuticals Limited has received final approval from the US Food and Drug Administration for its Abbreviated New Drug Application for Dapsone Gel, 5%. The final approval permits marketing of the product in the United States. The development was announced through a press release submitted to both BSE Limited and the National Stock Exchange of India Limited on June 26, 2026.
The approved ANDA is therapeutically equivalent to the reference listed drug product Aczone Gel, 5%, of Almirall, LLC. Dapsone Gel, indicated for the topical treatment of acne vulgaris, will be marketed in the US as a generic equivalent to Aczone Gel.
With this approval, Alembic's cumulative total of ANDA approvals from USFDA has reached 244. This includes 224 final approvals and 20 tentative approvals.
Headquartered in Vadodara, India, Alembic Pharmaceuticals Limited has been in the pharmaceutical sector since 1907. Alembic is a publicly listed company on BSE under scrip code 533573 and on NSE under symbol APLLTD. Alembic manufactures and markets generic pharmaceutical products worldwide and operates as a vertically integrated research and development pharmaceutical company. Its manufacturing and research facilities are approved by regulatory authorities of developed countries, including the USFDA.
In the Indian branded generics market, Alembic is one of the leaders with a field force of over 5,500 supporting its brands. The USFDA approval for Dapsone Gel, 5%, adds to Alembic's product portfolio in the dermatology segment of the US generics market.
Disclaimer: This article is based on company filings submitted to the Bombay Stock Exchange (BSE) and National Stock Exchange of India (NSE) and is for informational purposes only. It does not constitute investment advice or a recommendation. Investors should conduct their own research and consult a qualified financial advisor before making investment decisions.