Alembic Pharmaceuticals Secures USFDA Final Approval for Tretinoin Cream USP
Alembic Pharmaceuticals Limited has announced it has received final approval from the U.S. Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA), which covers Tretinoin Cream USP, 0.05%. The approved ANDA is therapeutically equivalent to Retin-A Cream, 0.05%, manufactured by Bausch Health US, LLC. This cream is indicated for topical application in the treatment of acne vulgaris.The market size for Tretinoin Cream USP, 0.05% is estimated at US$ 76 million for twelve months ending March 2026, according to IQVIA. This approval contributes to a strong track record for Alembic Pharmaceuticals Limited, which currently holds a cumulative total of 242 ANDA approvals from the USFDA, including 222 final and 20 tentative approvals.
Alembic Pharmaceuticals is a vertically integrated research and development pharmaceutical company with a history dating back to 1907. Headquartered in India, the publicly listed company manufactures and markets generic pharmaceutical products globally. Its state of the art facilities are approved by regulatory authorities of multiple developed countries, including the USFDA. Alembic is recognized as one of the leaders in branded generics in India, with its brands marketed through a field force exceeding 5,500 professionals.
APLLTD Stock Price Movement
Alembic Pharmaceuticals Limited rallies in live trading, with shares reaching ₹744.1 as of 1:38 PM after gaining 1.29%. The stock trades on a volume of 48,118 shares, indicating strong buying interest during the current market session.Disclaimer: Due care and diligence have been taken in compiling and presenting news and market-related content. However, errors or omissions may arise despite such efforts.
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