Strides gets USFDA nod for Prednisone tablets

Our Bureau Bengaluru | Updated on November 23, 2020

Strides Pharma Science Limited has announced that its step-down, wholly-owned subsidiary Strides Pharma Global Pte Limited, Singapore, has received approval for Prednisone Tablets USP (2.5 mg and 5 mg) from the US Food and Drug Administration (USFDA).

The company in a regulatory filing to stock exchanges said the product is bioequivalent and therapeutically equivalent to the reference listed drug Deltasone Tablets, 2.5 mg and 5 mg, of Pharmacia and Upjohn Co. Prednisone belongs to a class of drugs known as corticosteroids, and is used as an anti-inflammatory or an immunosuppressant medication in the treatment of different conditions such as allergic disorders, skin conditions, ulcerative colitis, arthritis, lupus, psoriasis, or breathing disorders

According to IQVIA MAT September 2020 data, the US market for Prednisone Tablets USP, 2.5 mg and 5 mg is about $30 million. The product will be manufactured at the company’s 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.

Published on November 23, 2020

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