Strides Pharma Global, a subsidiary of Strides Pharma Science, has received tentative approval from the US FDA for its generic Dolutegravir tablets used in HIV treatment. The approval allows the company to participate in global donor-funded programs that procure the medicine.
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.