Last Updated on December 31, 2023 by The Health Master
Mumbai: Lupin Limited announced that it has received tentative approval from the United States Food and Drug Administration (USFDA) under the US President’s Emergency Plan for AIDS Relief (PEPFAR) for its New Drug Application for Dolutegravir, Emtricitabine, and Tenofovir Alafenamide (DETAF) Tablets.
This product would be manufactured at Lupin’s Nagpur facility in India.
DETAF would be a new addition to the management of HIV infections and will be available for supplies to low- & middle-income countries.
Naresh Gupta, President, API and Global Institution Business, Lupin said, “We are committed to providing affordable and quality treatment options to patients in low- and middle-income countries.”
“We are pleased that the USFDA has tentatively approved DETAF, which will significantly enhance our HIV portfolio.”
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