Strides receives USFDA approval for Oxybutynin Chloride Tablets
Posted On: 2020-12-18 02:41:57 (Time Zone: Arizona, USA)
Strides Pharma Science Limited (Strides) today announced that its step-down 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 US$ 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.
Strides Pharma Science announced that its step-down wholly owned subsidiary, Strides Pharma Global, 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 US$ 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.
The company has 127 cumulative ANDA filings with USFDA of which 94 ANDAs have been approved
Strides Pharma Science rose 2.26% to Rs 788.50 after the drug maker announced that its step-down subsidiary has received approval for oxybutynin chloride tablets from the US drug regulator.The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), Ditropan tablets, 5 mg, of Janssen Pharmaceuticals, Inc.
The drug belongs to a class of drugs known as antispasmodics, used to treat overactive bladder and urinary conditions. It relaxes the muscles in the bladder to help decrease problems of urgency and frequent urination.
According to IQVIA MAT October 2020 data, the US market for oxybutynin chloride tablets is approximately $29 million. The company will manufacture the product at its Bengaluru facility. It will be marketed by Strides Pharma Inc. in the US market.
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.