Strides' subsidiary receives USFDA approval for Prednisone Tablets

Strides Pharma Science announced that its step-down wholly owned subsidiary, Strides Pharma Global, Singapore, has received approval for Prednisone Tablets USP, 2.5 mg and 5 mg from the United States Food & Drug Administration (USFDA). The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), Deltasone Tablets, 2.5 mg and 5 mg, of Pharmacia and Upjohn Co.

According to IQVIA MAT September 2020 data, the US market for Prednisone Tablets USP, 2.5 mg and 5 mg is approximately US$ 30 Mn. The product will be manufactured at the company's flagship facility at Bengaluru and will be marketed by Strides Pharma Inc. in the US market.

The company has 127 cumulative ANDA filings with USFDA of which 93 ANDAs have been approved and 34 are pending approval.

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