Alembic Pharmaceuticals 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.
The company has a cumulative total of 227 ANDA approvals (206 final approvals and 21 tentative approvals) from USFDA. Triamcinolone Acetonide Injectable Suspension USP is indicated for various autoimmune, inflammatory, and other conditions where oral therapy is not feasible.
Alembic Pharmaceuticals (Alembic Pharma) is involved in manufacturing and marketing of India Formulations, International Generics, and Active Pharmaceutical Ingredients with vertical integration capabilities.
