Alembic Pharmaceuticals Limited announces USFDA Final Approval for Tretinoin Cream USP, 0.05%

Alembic Pharmaceuticals Limited (Alembic) today announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Tretinoin Cream USP, 0.05%. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Retin-A Cream, 0.05%, of Bausch Health US, LLC. Tretinoin cream is indicated for topical application in the treatment of acne vulgaris. Refer label for a detailed indication.

Tretinoin Cream USP, 0.05%, has an estimated market size of US$ 76 million for twelve months ending March 2026 according to IQVIA.

Alembic has a cumulative total of 242 ANDA approvals (222 final approvals and 20 tentative approvals) from USFDA.

Shares of Alembic Pharmaceuticals Limited was last trading in BSE at Rs. 735.00 as compared to the previous close of Rs. 736.50. The total number of shares traded during the day was 12543 in over 609 trades.

The stock hit an intraday high of Rs. 759.70 and intraday low of 731.65. The net turnover during the day was Rs. 9340970.00.

Source : Equity Bulls

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AlembicPharmaceuticals INE901L01018 USFDA FinalApprovla TretinoinCream