Product Launch Details
Lupin Limited announced the U.S. FDA approval and subsequent launch of its Sugammadex Injection in the United States market. The approval was granted for the company's Abbreviated New Drug Application (ANDA).
Product Specifications
The product is available in two dosage strengths:
- 200 mg/2 mL (100 mg/mL) Single-Dose Vial
- 500 mg/5 mL (100 mg/mL) Single-Dose Vial
Therapeutic Indication
Sugammadex Injection is indicated for the reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide in:
- Adult patients
- Pediatric patients aged 2 years and older undergoing surgery
Bioequivalence and Reference Product
The product is bioequivalent to Bridion® Injection of Merck, Sharp & Dohme LLC (Merck). Bridion® is identified as a registered trademark of Merck Sharp & Dohme B.V.
Company Background Context
Lupin Limited is described as a global pharmaceutical leader 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 India and the U.S. across multiple therapy areas including respiratory, cardiovascular, anti-diabetic, anti-infective, gastrointestinal, central nervous system, and women's health.
Operational Scale
Lupin has:
- 15 state-of-the-art manufacturing sites globally
- 7 research centers globally
- Over 26,000 professionals in its workforce
Subsidiary Structure
The company operates through subsidiaries including:
- Lupin Diagnostics
- Lupin Digital Health
- Lupin Manufacturing Solutions
Disclosure Signatory
The announcement was digitally signed by Amit Kumar Gupta, Company Secretary & Compliance Officer (ACS -15754) of Lupin Limited.