Alembic Pharmaceuticals Ltd announces USFDA Final Approval for Triamcinolone Acetonide Injectable Suspension USP, 40 mg/mL

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) Triamcinolone Acetonide Injectable Suspension USP, 40 mg/mL Single-Dose Vials, 200 mg/5 mL and 400 mg/10 mL (40 mg/mL) Multiple-Dose Vials. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Kenalog-40 Injectable Suspension, of BristolMyers Squibb Company. Triamcinolone Acetonide Injectable Suspension USP is indicated for various autoimmune, inflammatory, and other conditions where oral therapy is not feasible. Refer label for a detailed indication.

Alembic has a cumulative total of 227 ANDA approvals (206 final approvals and 21 tentative approvals) from USFDA.

Triamcinolone Acetonide Injectable Suspension USP, 40 mg/mL, has an estimated market size of US$ 96 million for twelve months ending June 2025 according to IQVIA.

Shares of Alembic Pharmaceuticals Limited was last trading in BSE at Rs. 937.50 as compared to the previous close of Rs. 935.25. The total number of shares traded during the day was 1787 in over 484 trades.

The stock hit an intraday high of Rs. 950.20 and intraday low of 931.60. The net turnover during the day was Rs. 1679379.00.

Source : Equity Bulls

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AlembicPharmaceuticals INE901L01018 USFDA FinalApproval TriamcinoloneAcetonide InjectableSuspension