The approved abbreviated new drug application (ANDA) covers the injectable suspension at a concentration of 40 mg/mL, allowing Alembic to supply a key corticosteroid formulation in the U.S. generics market.

Alembic Pharma | The drugmaker had a topsy turvy ride after its March quarter results, eventually ending 3% lower. India's branded business showed strong growth for Alembic Pharma, while the US business grew by 20% year-on-year.

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Published Oct 18, 2025 | 9:13 AM GMT-04

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Indian pharmaceutical group Alembic Pharmaceuticals Ltd has secured final approval from the United States Food & Drug Administration (USFDA) for its generic version of Triamcinolone Acetonide Injectable Suspension USP 40 mg/mL on Saturday.

Triamcinolone Acetonide, a corticosteroid medication, works by reducing inflammation in the body, helping to relieve redness, itching, and swelling caused by various skin and allergic conditions.

The product is equivalent to the reference listed drug and will address demand for treatments involving joint-injection and intralesional administration of triamcinolone.

With this latest nod, Alembic now holds a total of 227 ANDA approvals (comprising 206 final approvals and 21 tentative approvals) from the USFDA.

As Alembic readies for commercial launch, the approval is expected to contribute to its U.S. generics business growth in the coming quarters, aligning with the company’s broader goal of capturing greater market share in the regulated markets of North America.

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