Lupin Limited announced on March 25, 2026, that it received tentative approval from the U.S. FDA for its Abbreviated New Drug Application (ANDA) for Pitolisant Tablets, 4.45mg and 17.8mg. These tablets are bioequivalent to Wakix®. Manufacturing will take place at Lupin’s facility in Nagpur, India. The announcement was made via a press release submitted to the stock exchanges.
Lupin Secures Tentative U.S. FDA Approval
Global pharmaceutical company Lupin Limited today, March 25, 2026, confirmed that it has received tentative approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application (ANDA). This approval pertains to the Pitolisant Tablets in two strengths: 4.45mg and 17.8mg.
The regulatory clearance signifies that the FDA has determined Lupin’s product to be bioequivalent to the reference listed drug, Wakix®, for the indication specified in the approved labeling. The tablets are intended to be manufactured at Lupin’s dedicated facility located in Nagpur, India.
Company Background and Reach
Lupin Limited, headquartered in Mumbai, India, operates as a leading global pharmaceutical company with product distribution spanning over 100 markets. The company specializes in a broad range of products, including generics, complex generics, biotechnology products, and APIs. Lupin maintains a robust global footprint, utilizing 15 state-of-the-art manufacturing sites and 7 research centers worldwide, supported by a workforce exceeding 22,000 professionals.
The company maintains a strong presence in key therapeutic areas across India and the U.S., including respiratory, cardiovascular, anti-diabetic, anti-infective, CNS, and women’s health.
Regulatory Submission Details
This disclosure was made pursuant to the requirements of the stock exchanges. The submission code provided for this equity segment was Equity – 500257.
The document was formally executed by Amit Kumar Gupta, Company Secretary & Compliance Officer (ACS-15754), and submitted to the National Stock Exchange and BSE Limited.
Source: BSE
