Alembic Pharmaceuticals Limited has secured final approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Tretinoin Cream USP, 0.05%, further strengthening its dermatology portfolio in the US market. The approved product is the generic equivalent of Retin-A Cream, 0.05%, marketed by Bausch Health US, LLC. Tretinoin Cream is widely prescribed for the topical treatment of acne vulgaris and is recognized as a key therapy in dermatological care.
The approval adds another important product to Alembic’s expanding portfolio of regulated-market offerings and reinforces the company’s commitment to providing high-quality, affordable medicines to patients worldwide. The development also reflects the company’s continued investment in research, formulation development, and regulatory compliance aimed at addressing growing healthcare needs across global markets.
According to industry estimates, the US market for Tretinoin Cream USP, 0.05% generated approximately US$76 million in annual sales for the twelve-month period ending March 2026. With this approval, Alembic is well-positioned to participate in a competitive and established therapeutic segment while expanding its presence within the dermatology category.
The latest approval increases Alembic’s cumulative USFDA ANDA approvals to 242, comprising 222 final approvals and 20 tentative approvals. This milestone highlights the company’s consistent success in navigating stringent regulatory pathways and bringing complex generic products to market.
Alembic continues to pursue a diversified pipeline across multiple therapeutic areas, supported by state-of-the-art manufacturing facilities and advanced research capabilities. Its vertically integrated business model enables efficient product development, manufacturing, and commercialization across international markets.
Founded in 1907, Alembic Pharmaceuticals has evolved into one of India’s leading pharmaceutical organizations with a strong footprint in both domestic and global markets. The company manufactures and markets a broad portfolio of generic formulations and active pharmaceutical ingredients while maintaining a strong focus on quality, innovation, and patient care.
Its manufacturing facilities are approved by leading international regulatory authorities, including the USFDA, enabling the company to serve healthcare systems across developed and emerging markets. In India, Alembic remains a prominent player in the branded generics segment, supported by an extensive field force and a portfolio of trusted brands prescribed by healthcare professionals nationwide.
