The drug major bagged tentative approval from the USFDA under the US President's Emergency Plan for AIDS Relief for its New Drug Application for Dolutegravir, Lamivudine & Tenofovir Disoproxil Fumarate tablets and antiretroviral Fixed Dose Combinatio
This product would be manufactured at Lupin's Nagpur facility (Maharashtra) in India. Lamivudine and Tenofovir Disoproxil Fumarate Tablets (TLD) is recommended by World Health Organisation (WHO), the U.S. Agency for International Development (USAID), and U.S. President's Emergency Plan (PEPFAR) as a preferred first-line treatment regimen for the treatment of HIV in adults and pediatric patients weighing at least 35 kg, and will be available for supplies to low-and- middle-income countries (LMIC).
Commenting on the United States Food and Drug Administration (USFDA)'s tentative approval, Naresh Gupta, the president of API Plus, Lupin, has said that: "I am delighted that we have received FDA's tentative approval for TLD. It is a significant approval for Lupin which has recently forayed into HIV business arena. We have a deep commitment to increasing access to quality and affordable treatment options for low-and-middle-income countries for decades. Being integrated with in-house manufacture of APIs and formulations gives us an opportunity to provide quality products and uninterrupted supplies for affordable access for patients in these countries."
The drug major's consolidated net profit jumped 18.7% to Rs 464.37 crore on 0.8% fall in net sales to Rs 3,759.27 crore in Q4 March 2021 over Q4 March 2020. Lupin is an innovation-led transnational pharmaceutical company.
Shares of Lupin shed 0.56% to Rs 1,154.55 on BSE. The scrip hovered in the range of Rs 1,146.20 to Rs 1,168.05 so far.
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