Alembic Pharmaceuticals Limited has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Tretinoin Cream USP, 0.05%. This approved ANDA is therapeutically equivalent to the reference listed drug product. The company also announced an estimated market size of US$76 million for the product for the twelve months ending March 2026. This marks another significant milestone for Alembic in the US market.
USFDA Final Approval Secured
Alembic Pharmaceuticals Limited has announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Tretinoin Cream USP, 0.05%. This approval signifies a key achievement for the company in the United States market.
Product and Market Potential
The approved ANDA for Tretinoin Cream USP, 0.05%, is therapeutically equivalent to the reference listed drug product, Retin-A Cream, 0.05%. Tretinoin cream is indicated for topical application in the treatment of acne vulgaris. According to IQVIA, the estimated market size for Tretinoin Cream USP, 0.05%, was US$ 76 million for the twelve months ending March 2026.
Company Milestones
With this latest approval, Alembic Pharmaceuticals Limited has achieved a cumulative total of 242 ANDA approvals from the USFDA, comprising 222 final approvals and 20 tentative approvals. The company has also enclosed its press release for further details regarding this significant development.
About Alembic Pharmaceuticals Limited
Alembic Pharmaceuticals Limited is a vertically integrated research and development pharmaceutical company, established in 1907 and headquartered in India. The company manufactures and markets generic pharmaceutical products globally. Its state-of-the-art research and manufacturing facilities are approved by regulatory authorities in numerous developed countries, including the USFDA. Alembic is recognized as a leader in branded generics within India, with its brands marketed by a field force of over 5500 professionals.
Source: BSE
