Strides Pharma Science Singapore gets tentative USFDA approval for Dolutegravir/ Lamivudine/ Tenofovir Disproxil Fumurate tablets
Bangalore: Strides Pharma Science Limited has announced that its step‐ down wholly owned subsidiary, Strides Pharma Global Pte. Limited, Singapore, has received tentative approval for its New Drug Application (NDA) 505b2 of Dolutegravir/ Lamivudine/ Tenofovir Disproxil Fumurate 50mg/ 300mg/ 300mg tablets from the United States Food & Drug Administration (USFDA).
The Product will be manufactured at the company’s facility in Bengaluru.
Approval of this product under the PEPFAR program completes Strides’ qualification to all major markets and donor programs including Global Fund and South Africa. The PEPFAR tentative approval for Strides qualifies the Company to participate in the PEPFAR programs that procure this lifesaving medicine. Through country tenders and donor funded programs it is estimated that the value of procurement for Dolutegravir/ Lamivudine/ Tenofovir Disproxil Fumurate 50mg/ 300mg/ 300mg tablets is ~650mn USD.
The Company has 260+ cumulative NDA/ ANDA filings with USFDA, of which 230+ ANDAs have been approved. The Company has set a target to launch ~ 60 new products over the next three years in the US.
Dolutegravir/ Lamivudine/ Tenofovir Disproxil Fumurate 50mg/ 300mg/ 300mg tablets is a complete regimen for treatment of HIV‐1 infection in adults and pediatric patients weighing at least 35kgs.
Strides, a global pharmaceutical company headquartered in Bengaluru, India, is listed on the BSE Limited (532531) and National Stock Exchange of India Limited (STAR). The Company mainly operates in the regulated markets and has an “in Africa for Africa” strategy and 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 (New York).
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