Alembic Pharma Receives USFDA Approval for Injectable Drug

Alembic Pharmaceuticals Limited has secured final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Triamcinolone Acetonide Injectable Suspension USP, 40 mg/mL, single-dose vials (200 mg/5 mL), and multiple-dose vials (400 mg/10 mL) are the forms of the drug.

The injection is indicated for the treatment of different autoimmune, inflammatory, and other pathological conditions in which the administration of the drug by mouth is not possible. The approval is a step forward for Alembic Pharma to establish its brand in the US generic pharmaceutical market.

Alembic Pharma's total ANDA approvals are at 227, out of which 206 are final approvals, and 21 are tentative approvals by the USFDA. It is a clear indication of the company's sustained efforts towards regulatory compliance and maintaining high standards of production quality.

Also Read: Aster DM Healthcare, Dubai, and XLRI Jamshedpur sign MoU

As per IQVIA, Triamcinolone Acetonide Injectable Suspension USP, 40 mg/mL, is a product with a US market size of around $96 million over the past twelve months period ending June 2025, thus, having significant commercial potential.

Located in India, Alembic Pharmaceuticals is a fully integrated R&D pharmaceutical company of the generic segment. It not only produces but also sells a wide range of generic pharmaceutical products worldwide. The cutting-edge research and production units of the company have the seal of approval from several international regulatory authorities, including the USFDA, which ensures compliance with worldwide quality standards.

This USFDA nod aligns with Alembic Pharma’s strategy to penetrate deeper into the international market, meet the rising demand for quality and affordable drugs, and at the same time, strengthen its position as one of the major generic pharmaceuticals ‍players.