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Strides Pharma Global Pte Ltd, Singapore, a step-down wholly-owned subsidiary of Strides Pharma Science Ltd, has received approval for Triamcinolone Acetonide Ointment USP 0.05 per cent from the United States Food & Drug Administration (USFDA).
Triamcinolone Acetonide Ointment is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses.
The product is part of the niche and small volume product portfolio with limited competition in the US market, the company said in a statement.
According to IQVIA MAT data, the US market for Triamcinolone Acetonide Ointment is about $15 million. The product will be manufactured at the company’s flagship facility in Bengaluru and will be marketed by Strides Pharma Inc. in the US market.
The company has 124 cumulative ANDA filings with USFDA of which 86 ANDAs have been approved and 38 are pending approval.
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