Lupin Receives Tentative Approval from U.S. FDA for Amifampridine Tablets

Mumbai, Naples, March 17, 2025: Global pharma major Lupin Limited (Lupin) today 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 Amifampridine Tablets, 10 mg. This product would be manufactured at Lupin’s Goa facility in India.

Amifampridine Tablets, 10 mg, are bioequivalent to Firdapse® Tablets, 10 mg of Catalyst Pharmaceuticals, Inc., and are indicated for the treatment of Lambert-Eaton myasthenic syndrome in adults and pediatric patients 6 years of age and older.

Amifampridine Tablets, 10 mg (RLD Firdapse®) had an estimated global net sale of USD 306 million for the fiscal year ended December 31, 2024.

About Lupin  
Lupin Limited is a global pharmaceutical leader headquartered in Mumbai, India, with products distributed in over 100 markets. Lupin specializes in pharmaceutical products, including branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients. Trusted by healthcare professionals and consumers globally, the company enjoys a strong position in India and the U.S. across multiple therapy areas, including respiratory, cardiovascular, anti-diabetic, anti-infective, gastrointestinal, central nervous system, and women's health. Lupin has 15 state-of-the-art manufacturing sites and 7 research centers globally, along with a dedicated workforce of over 23,000 professionals. Lupin is committed to improving patient health outcomes through its subsidiaries - Lupin Diagnostics, Lupin Digital Health, and Lupin Manufacturing Solutions. 
To know more, visit www.lupin.com or follow us on LinkedIn https://www.linkedin.com/company/lupin    

For further information or queries please contact –
Rajalakshmi Azariah 
Vice President & Global Head – Corporate Communications, Lupin  
rajalakshmiazariah@lupin.com   

*Safe Harbor Statement
Firdapse® is a registered trademark of SERB