Strides Pharma gets USFDA nod for Emtricitabine, Tenofovir Disoproxil Fumarate Tablets to treat HIV
Bengaluru: Strides Pharma Science Limited has recently announced that the company's step-down wholly owned subsidiary, Strides Pharma Global Pte. Limited, 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.
Emtricitabine and tenofovir belong to class of medications called nucleoside and nucleotide reverse transcriptase inhibitors. The combination of Emtricitabine and Tenofovir slows down the spread of HIV in the body and is used along with other medications to treat HIV in adults and children.
The product will be manufactured at the company's facility at Bengaluru and will be marketed by Strides Pharma Inc. in the US market.
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 company has 127 cumulative ANDA filings with USFDA of which 95 ANDAs have been approved and 32 are pending approval.
Strides is a global pharmaceutical company headquartered in Bangalore, India. The Company mainly operates in the regulated markets and has an "in Africa for Africa" strategy along with an institutional business to service donor‐funded markets.
The Company's global manufacturing sites are located in India‐ Bangalore (two locations), Pondicherry, and Chennai, Singapore, Italy‐ Milan, Kenya‐ Nairobi and United States‐Florida.