Mumbai:
- Lupin Limited, a leading global pharmaceutical company, revealed today that it has obtained approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application concerning Febuxostat Tablets in 40 mg and 80 mg strengths. This approval allows Lupin to introduce a generic version of Takeda Pharmaceuticals U.S.A., Inc.’s Uloric Tablets in the same strengths. The manufacturing of this product will take place at Lupin’s facility in Pithampur, India.
- Febuxostat Tablets, available in 40 mg and 80 mg strengths, are prescribed for the continual treatment of hyperuricemia in adult individuals with gout. This includes those who have not responded adequately to the highest recommended dose of allopurinol, individuals intolerant to allopurinol, or those for whom allopurinol treatment is not recommended.
- The estimated annual sales for Febuxostat Tablets (Reference Listed Drug: Uloric) in the U.S. were USD 27 million, as per IQVIA MAT data for November 2023.
About Lupin :
- Lupin, headquartered in Mumbai, India, stands as an innovation-driven multinational pharmaceutical firm. The company specializes in the development and commercialization of a diverse portfolio encompassing branded and generic formulations, biotechnology products, and APIs. Operating across more than 100 markets spanning the U.S., India, South Africa, as well as regions across Asia Pacific (APAC), Latin America (LATAM), Europe, and the Middle East, Lupin is a key player in the global pharmaceutical arena.
- With a strong foothold in cardiovascular, anti-diabetic, and respiratory segments, Lupin holds a leadership position in these therapeutic areas. Additionally, the company has significant presence in segments like anti-infective, gastro-intestinal (GI), central nervous system (CNS), and women’s health. Lupin is recognized as the third-largest pharmaceutical company in the U.S. based on prescriptions filled. Notably, the company allocates 7.9% of its revenue towards research and development endeavors as of FY23.
- Lupin’s operational infrastructure includes 15 manufacturing sites, 7 research centers, and a global workforce of over 20,000 professionals. The company consistently earns accolades as a ‘Great Place to Work’ in the Biotechnology & Pharmaceuticals sector, reflecting its commitment to fostering a positive and inclusive work environment.