Wednesday, April 16, 2025
The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug, Truvada Tablets, 200 mg/300 mg, of Gilead Sciences
Strides Pharma Science Limited today announced that it's a 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.
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 and 32 are pending approval.
About Emtricitabine and Tenofovir Disoproxil Fumarate Tablets: Emtricitabine and tenofovir belong to a 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.
Strides, listed, is a global pharmaceutical company headquartered in Bengaluru, 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 (Chennai, Puducherry and two locations in Bengaluru), Singapore, Italy (Milan), Kenya (Nairobi) and the United States (Florida). The Company focusses on “difficult to manufacture” products that are sold in over 100 countries.
.jpeg)
.jpeg)
.jpeg)
.jpeg)
_(1).jpeg)
_(1)_(1)_(1).jpeg)
.jpeg)
.jpeg)
.jpeg)
.jpeg)
.jpeg)