Lupin Receives USFDA Tentative Approval for Generic HIV Drug

Lupin Limited, a key player in the pharmaceutical industry, has received tentative approval from the United States Food and Drug Administration (USFDA) for its generic version of an HIV treatment. This development marks another step in the company’s ongoing efforts to expand its global portfolio, particularly in the United States.

Details of the Approval

The approval pertains to Lupin’s Abbreviated New Drug Application (ANDA) for a combination drug comprising Darunavir, Cobicistat, Emtricitabine, and Tenofovir Alafenamide in the 800 mg/150 mg/200 mg/10 mg dosage format. Notably, Lupin holds an exclusive first-to-file status for this generic medication, giving it a competitive advantage in the market upon final approval.

Manufacturing at Lupin’s Nagpur Facility

The newly approved product will be manufactured at Lupin’s state-of-the-art facility in Nagpur, India. This further strengthens the company’s manufacturing footprint and reinforces India’s position as a global pharmaceutical hub.

Regulatory and Market Impact

While this approval is a significant achievement, Lupin has clarified that it does not constitute a material event under the SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015. Therefore, the company was not required to make an official stock exchange disclosure.

Zero Observation 

Earlier this month, Lupin announced that the United States Food and Drug Administration (U.S. FDA) has completed a Pre-Approval Inspection (PAI) of Edaravone Oral Suspension, 105 mg/ 5 mL at its manufacturing facility in Somerset, New Jersey. The inspection was carried out from January 28 to February 1, 2025, and concluded with zero 483 observations.

Share Price Movement

As of 10:07 AM on February 5, 2025, Lupin’s share price has gained over 2.5%, trading at ₹2,170.

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