Strides Pharma Science’s arm gets USFDA approval for Prednisone Tablets

23 Nov 2020 Evaluate

Strides Pharma Science’s step-down wholly owned subsidiary -- Strides Pharma Global Pte., 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 $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. 

Strides Pharma Science (Formerly Strides Shasun) is a pharmaceutical company with a major focus on development and manufacture of IP-led niche finished dosage formulations. It is also among the world’s largest manufacturers of soft gelatin capsules.

Strides Pharma Scien Share Price

843.00 -1.05 (-0.12%)
19-Apr-2024 16:01 View Price Chart
Peers
Company Name CMP
Sun Pharma Inds. 1525.00
Dr. Reddys Lab 5942.65
Cipla 1345.35
Zydus Lifesciences 925.95
Lupin 1547.05
View more..
© 2024 The Alchemists Ark Pvt. Ltd. All rights reserved. MoneyWorks4Me ® is a registered trademark of The Alchemists Ark Pvt.Ltd.