Lupin Receives Approval from U.S. FDA for Doxycycline for Injection USP

Lupin Limited, a global pharmaceutical powerhouse, has secured approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application concerning Doxycycline for Injection USP, 100 mg/Vial (Single-Dose Vial). This green light from the FDA allows Lupin to introduce a generic counterpart to Pfizer Inc.’s Vibramycin® for Injection, 100 mg/Vial. The manufacturing of this product will take place at Lupin’s Nagpur facility in India.

Doxycycline for Injection USP serves the vital purpose of curtailing the development of drug-resistant bacteria while ensuring the efficacy of Doxycycline and other antibacterial medications. It is intended solely for the treatment or prevention of infections confirmed or strongly suspected to be bacterial in nature.

The estimated annual sales of Doxycycline for Injection USP (RLD Vibramycin®) in the U.S. stand at approximately USD 47 million, as per IQVIA MAT data from January 2024.

Lupin, headquartered in Mumbai, India, is an innovative multinational pharmaceutical enterprise. It spearheads the development and commercialization of a diverse array of branded and generic formulations, biotechnology products, and active pharmaceutical ingredients (APIs) across more than 100 markets worldwide. Its reach extends to the United States, India, South Africa, and various regions across Asia Pacific (APAC), Latin America (LATAM), Europe, and the Middle East.

The company boasts a dominant presence in cardiovascular, anti-diabetic, and respiratory segments, along with significant contributions in anti-infective, gastro-intestinal (GI), central nervous system (CNS), and women’s health domains. Lupin holds the distinction of being the third-largest pharmaceutical firm in the U.S. in terms of prescriptions filled. In the fiscal year 2023, the company allocated 7.9% of its revenue towards research and development.

With 15 manufacturing sites, 7 research centers, and a workforce exceeding 20,000 professionals worldwide, Lupin has consistently earned recognition as a ‘Great Place to Work’ in the Biotechnology & Pharmaceuticals sector.

Source Link

Newsletter Updates

Enter your email address below and subscribe to our newsletter