Regulatory Approval Announcement
Lupin Limited announced that it has received approval from the United States Food and Drug Administration (US FDA) for its Abbreviated New Drug Applications (ANDA) for Amifampridine Tablets, 10 mg. The approval was granted on November 2, 2026.
Product Details
The approved product is bioequivalent to the reference listed drug (RLD) Firdapse® Tablets, 10 mg, manufactured by Catalyst Pharmaceuticals, Inc. Firdapse® is a registered trademark of SERB S.A.
Market Exclusivity
Lupin is one of the first ANDA applicants for this product and is eligible for 180 days of shared generic exclusivity in the United States market as a first-to-file applicant.
Company Background Context
Lupin Limited is a global pharmaceutical company headquartered in Mumbai, India, with operations spanning India, the U.S., Other Developed Markets, and Emerging Markets. The company distributes products in over 100 markets and maintains a diversified portfolio including generics, complex generics, specialty medicines, and biosimilars. Lupin has leadership positions in therapeutic areas including cardiovascular, respiratory, diabetes, gastrointestinal, and women's health. The company operates 15 manufacturing facilities and 6 research centers, employing over 26,000 professionals globally.
Disclosure Compliance
The announcement was made pursuant to Regulation 30 of the SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015, signed by Amit Kumar Gupta, Company Secretary & Compliance Officer of Lupin Limited.