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
Synopsis
Drug firm Strides Pharma Science on Friday said its step-down wholly-owned subsidiary, Strides Pharma Global, has received approval from the US health regulator for Emtricitabine and Tenofovir Disoproxil Fumarate tablets, used to treat HIV.
Agencies
Drug firm
Strides Pharma Science on Friday said its step-down wholly-owned subsidiary, Strides Pharma Global, has received approval from the US health regulator for Emtricitabine and Tenofovir Disoproxil Fumarate tablets, used to treat HIV. The approved product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Truvada tablets of Gilead Sciences. Strides Pharma Global, Singapore, has received approval for Emtricitabine and Tenofovir Disoproxil Fumarate tablets in the strengths of 200 mg/300 mg from the United States Food and Drug Administration (USFDA), Strides Pharma Science said in a regulatory filing.
Drug firm Strides Pharma Science on Friday said its step-down wholly-owned subsidiary, Strides Pharma Global, has received approval from the US health regulator for Emtricitabine and Tenofovir Disoproxil Fumarate tablets, used to treat HIV. The approved product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Truvada tablets of Gilead Sciences. Strides Pharma Global, Singapore, has received approval for Emtricitabine and Tenofovir Disoproxil Fumarate tablets in the strengths of 200 mg/300 mg from the United States Food and Drug Administration (USFDA), Strides Pharma Science said in a regulatory filing. Quoting IQVIA moving annual total (MAT) November 2020 data, Strides Pharma Science said the US market for Emtricitabine and Tenofovir Disoproxil Fumarate Tablets, 200 mg/300 mg is approximately USD 2.4 billion.
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.