Lupin Limited, a global pharmaceutical leader, has announced that it has received tentative approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application for Pitolisant Tablets, in dosages of 4.45mg and 17.8mg. The tablets are set to be manufactured at Lupin’s Nagpur facility in India.
The approval from the U.S. FDA indicates that Lupin’s Pitolisant Tablets are bioequivalent to Wakix®, as per the approved labelling. This development marks a significant step for Lupin in expanding its portfolio of pharmaceutical products in the U.S. market.
Lupin Limited is headquartered in Mumbai, India, and has a strong presence in over 100 markets globally. The company specialises in a wide range of pharmaceutical products, including branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients. Lupin is recognised for its strong foothold in therapy areas such as respiratory, cardiovascular, anti-diabetic, anti-infective, gastrointestinal, central nervous system, and women’s health.
The company operates 15 state-of-the-art manufacturing sites and seven research centres worldwide, supported by a dedicated workforce of over 22,000 professionals. Lupin is committed to improving patient health outcomes through its subsidiaries, including Lupin Diagnostics, Lupin Digital Health, and Lupin Manufacturing Solutions.
For further information, interested parties can contact Rajalakshmi Azariah, Vice President & Global Head of Corporate Communications at Lupin, or Elise Titan, Director of U.S. Communications at Lupin.
Disclaimer: This article is based on a regulatory filing submitted to the National Stock Exchange of India (NSE).