Strides Pharma Science Gets USFDA Nod For Generic Drug moneycontrol.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from moneycontrol.com Daily Mail and Mail on Sunday newspapers.
Bengaluru-based Strides Pharma has 127 cumulative abbreviated new drug applications (ANDA) filings with USFDA of which 96 have been approved and 31 are pending approval.
Strides Pharma Global Pte Ltd receives approval for Oxybutynin Chloride tablets USP
Bengaluru, Dec 18 (UNI) Strides Pharma Science Limited (Strides) s a wholly-owned subsidiary, Strides Pharma Global Pte Limited, Singapore, has received approval for Oxybutynin Chloride Tablets USP, 5 mg from the United States Food & Drug Administration (USFDA).
The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), Ditropan Tablets, 5 mg, of Janssen Pharmaceuticals, Inc.
According to IQVIA MAT October 2020 data, the US market for Oxybutynin Chloride Tablets USP, 5 mg is approximately USD 29 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.