The approved product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD) Deltasone tablets, 10 mg and 20 mg, of Pharmacia and Upjohn Co.
New Delhi, Feb 12: Drug firm Strides Pharma Science on Friday said its subsidiary, Strides Pharma Global Pte Ltd, has received approval from the US health
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 Science announced that its
step-down wholly owned subsidiary, Strides Pharma Global, Singapore, has received
approval for Ursodiol Capsules USP, 300 mg from the United States Food & Drug Administration
(USFDA).
The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug
(RLD), Actigall Capsules, 300 mg, of Allergan Sales, LLC.
According to IQVIA MAT November 2020 data, the US market for Ursodiol Capsules USP, 300 mg is
approximately US$ 45 Mn. 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 96 ANDAs have been approved