Alembic Pharmaceuticals Limited announces USFDA Final Approval for Triamcinolone Acetonide Injectable Suspension USP, 40 mg/mL
Vadodara, 20th October, 2025: 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 Bristol-Myers 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.
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.
Alembic has a cumulative total of 227 ANDA approvals (206 final approvals and 21 tentative approvals) from USFDA.
