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.
The product will be manufactured at the company’s facility at Bengaluru and will be marketed by Strides Pharma in the US market,” the company added. The company has 127 cumulative abbreviated new drug application (ANDA) filings with USFDA of which 95 ANDAs have been approved and 32 are pending approval. Shares of Strides Pharma Science were trading 0.83 per cent higher at Rs 929 apiece on BSE.
