Date: August 17, 2026
Regulatory Approval Disclosure
Lupin Limited announced it has received final approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application (ANDA) for Pitolisant Tablets.
Product Details
- Approved strengths: 4.45 mg and 17.8 mg
- Bioequivalence: Approved as bioequivalent to Wakix® (reference product)
- Indications: Approved for all indications in the approved labeling of Wakix®
Company Context
Lupin is a global pharmaceutical company headquartered in Mumbai, India, with products distributed in over 100 markets. The company specializes in:
- Branded and generic formulations
- Complex generics
- Biotechnology products
- Active pharmaceutical ingredients
The company maintains a strong position in multiple therapy areas including respiratory, cardiovascular, anti-diabetic, anti-infective, gastrointestinal, central nervous system, and women's health.
Corporate Infrastructure
- 15 state-of-the-art manufacturing sites globally
- 6 research centers globally
- Over 26,000 professionals in workforce
- Key subsidiaries: Lupin Diagnostics, Lupin Digital Health, and Lupin Manufacturing Solutions
Disclosure Context
This announcement was made pursuant to Regulation 30 of the SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015. The press release was signed by Amit Kumar Gupta, Company Secretary & Compliance Officer (ACS -15754).
Trademark Information
Wakix® is a registered trademark of Bioprojet Europe, Ltd.