- Alembic Pharmaceuticals receives USFDA approval for Tretinoin Cream USP (0.025%).
- The cream is therapeutically equivalent to Bausch Health’s Retin-A Cream.
- Market size for Tretinoin cream is estimated at USD 94 million by June 2025.
Alembic Pharmaceuticals has received approval from the U.S. Food and Drug Administration (USFDA) for its generic Tretinoin Cream USP (0.025%). This cream is indicated for the treatment of acne vulgaris and is therapeutically equivalent to Bausch Health US, LLC’s branded product, Retin-A Cream. The approval is part of Alembic’s strategy to expand its dermatology portfolio. The market for Tretinoin cream USP (0.025%) is projected to reach approximately USD 94 million for the twelve months ending June 2025, indicating a significant opportunity for Alembic in the dermatological space. The approval allows Alembic to compete directly in a market that has established demand, potentially increasing its market share in the U.S. pharmaceutical landscape. This move aligns with Alembic’s ongoing efforts to enhance its product offerings and address the needs of patients suffering from acne vulgaris.
Insights
This approval enhances Alembic’s portfolio and targets a market worth USD 94 million.