Alembic Pharmaceuticals Limited, a vertically integrated pharmaceutical company headquartered in Vadodara, India, has announced in a press release dated June 12, 2026, that it has received final approval from the US Food and Drug Administration for its Abbreviated New Drug Application for Tretinoin Cream USP, 0.05%.
The USFDA approval confirms that Alembic's Tretinoin Cream USP, 0.05%, is therapeutically equivalent to the reference listed drug product, Retin-A Cream, 0.05%, manufactured by Bausch Health US, LLC, and is indicated for the topical treatment of acne vulgaris.
According to IQVIA data, the estimated market size for Tretinoin Cream USP, 0.05%, in the United States is US$ 76 million for the twelve-month period ending in March 2026, based on sales information.
This approval increases Alembic Pharmaceuticals' cumulative total of ANDA approvals from the USFDA to 242, comprising 222 final approvals and 20 tentative approvals.
Alembic Pharmaceuticals Limited was established in 1907 and operates research and manufacturing facilities that are approved by regulatory authorities, including the USFDA, ensuring high-quality pharmaceutical production.
The company is publicly listed on the National Stock Exchange of India under the ticker symbol APLLTD and on the Bombay Stock Exchange with code 533573, and it maintains a field force of over 5500 for its branded generics business in India.
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.