Companies

Strides Pharma gains 3 per cent on FDA approval for Prednisone Tablets

Our Bureau Mumbai | Updated on February 12, 2021 Published on February 12, 2021

The product will be manufactured at Bengaluru facility

The shares of Strides Pharma Science Limited (Strides) gained 3 per cent during the afternoon trade on Friday after the company announced that it had received approval for Prednisone Tablets USP, 10 mg and 20 mg from the United States Food & Drug Administration (USFDA).

At 1:13 pm, Strides Pharma was trading at ₹895.40 on the BSE, up ₹29.60 or 3.42 per cent.

It hit an intraday high of ₹902.25 and an intraday low of ₹868.45. It opened at ₹873.25 as against the previous close of ₹865.80.

On the NSE, it was trading at ₹895.00, up ₹28.75 or 3.32 per cent. It hit an intraday high of ₹902.00 and an intraday low of ₹866.30.

ANDA filings

The company on Friday announced that its step-down wholly-owned subsidiary, Strides Pharma Global Pte. Limited, Singapore, had received approval for Prednisone Tablets USP, 10 mg and 20 mg from the USFDA.

“The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), Deltasone Tablets, 10 mg and 20 mg, of Pharmacia and Upjohn Co. (Pharmacia). According to IQVIA MAT December 2020 data, the US market for Prednisone Tablets USP, 10 mg and 20 mg is approximately US$ 60 Mn,” the company said in an official release.

The company will manufacture the product at its facility at Bengaluru and it will be marketed by Strides Pharma Inc in the US market. The company has 127 cumulative ANDA filings with USFDA of which 98 ANDAs have been approved and 29 are pending approval.

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Published on February 12, 2021
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