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
Strides Pharma Science announced that its step-down wholly owned subsidiary, Strides Pharma Global, Singapore, has received
approval for Emtricitabine and Tenofovir Disoproxil Fumarate Tablets, 200 mg/300 mg from the United States Food & Drug Administration (USFDA).
The product is bioequivalent and therapeutically
equivalent to the Reference Listed Drug (RLD), Truvada Tablets, 200 mg/300 mg, of Gilead Sciences.
According to IQVIA MAT November 2020 data, the US market for Emtricitabine and Tenofovir Disoproxil
Fumarate Tablets, 200 mg/300 mg is approximately US$ 2.4 Bn. 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 95 ANDAs have been approved
Cipla recalls 5.8 lakh packets of gastric ulcer treatment drug from US market
The drug firm has manufactured the affected lot at its Kurkumbh facility in Maharashtra and then supplied to its New Jersey-based subsidiary
PTI | January 10, 2021 | Updated 14:07 IST
The USFDA cited cross-contamination with other products as the reason for the company recalling the product
Drug major Cipla is recalling over 5.8 lakh packets of a drug for the reduction in the occurrence of gastric ulcers from the US market, as per a report by the US Food and Drug Administration. The drug major is recalling esomeprazole magnesium for delayed-release oral suspension in unit dose packets in strengths 10 mg, 20 mg and 40 mg in the US market, the latest Enforcement Report by the USFDA said.
Drug major Cipla is recalling over 5.8 lakh packets of a drug for the reduction in the occurrence of gastric ulcers from the US market, as per a report by the US Food and Drug Administration. The drug major is recalling esomeprazole magnesium for delayed-release oral suspension in unit dose packets in strengths 10 mg, 20 mg and 40 mg in the US market, the latest Enforcement Report by the USFDA said. The drug firm has manufactured the affected lot at its Kurkumbh facility in Maharashtra and then supplied to its New Jersey-based subsidiary. The USFDA cited cross-contamination with other products as the reason for the company recalling the product.
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.