Strides Pharma gets USFDA nod for Triamcinolone Acetonide cream

The product is the generic version of a Mylan Pharma product, the company has said.

Feb 13, 2019 05:02 IST India Infoline News Service

Strides Pharma Science Ltd (Strides), on Wednesday, announced that its step-down, wholly-owned subsidiary Strides Pharma Global Pte Ltd, Singapore, has received the US health regulator's (USFDA) approval for Triamcinolone Acetonide Cream USP, 0.025%, 0.1%, and 0.5%. 

The product is the generic version of Mylan Pharmaceuticals' Triamcinolone Acetonide cream, the company said in a regulatory filing. The product will be manufactured at the company's flagship facility in Bengaluru and will be marketed by Strides Pharma Inc. in the US markets. 

According to IQVIA MAT data, the US market for Triamcinolone Acetonide Cream USP, 0.025%, 0.1%, and 0.5%, is ~$55mn.

The company has 86 cumulative ANDA filings with the USFDA, of which, 56 ANDAs have been approved, including 12 approvals received in FY19.

Strides Pharma Science Ltd share price is currently at Rs405.30, down Rs6.95, or 1.69%, from its previous close of Rs412.25 on the BSE. The scrip opened at Rs416.50 and has touched a high and low of Rs420 and Rs400.60, respectively.

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