US FDA inspection closed at its Injectable Facility with Zero 483 observations: Lupin
Jun 14, 2024
New Delhi [India], June 14 : Lupin Limited, a global pharmaceutical company, said that the United States Food and Drug Administration (FDA) has completed an inspection of its Injectable facility at Nagpur.
According to the stock market filing with the National Stock Exchange, Lupin says the U.S. FDA carried out the inspection between June 10 to June 13, 2024, and concluded with zero 483 observations.
The pharma major said in its filing, "The United States Food and Drug Administration (U.S. FDA) has completed an inspection of its injectable facility in Nagpur, India."
In May this year, the U.S. FDA conducted a pre-approval inspection of Lupin's manufacturing facility in Somerset, New Jersey. After the inspection, the American federal agency issued a Form 483 containing six observations. Issuance of such observations indicates potential violations of regulatory significance.
Earlier in April, the U.S. FDA did a GMP Inspection of Lupin's Active Pharmaceutical Ingredients (API) manufacturing facility located at Dabhasa.
Lupin is the third-largest pharmaceutical company in the U.S. by prescriptions. The company invested 7.8 per cent of its revenue in research and development in FY24.The pharma major has 15 manufacturing sites, 7 research centers and more than 20,000 professionals working globally.
A trans-national pharmaceutical company, Lupin is headquartered at Mumbai. The Company develops and commercializes a wide range of branded and generic formulations, biotechnology products, and APIs in over 100 markets in the U.S., India, South Africa, and across the Asia Pacific (APAC), Latin America (LATAM), Europe, and Middle East regions.
The Company possess a leadership position in the cardiovascular, anti-diabetic, and respiratory segments and has a significant presence in the anti-infective, gastro-intestinal (GI), central nervous system (CNS), and women's health areas.
Lupin shares on Friday were trading in green with a slight up of 0.75 points at around Rs 1606 at the NSE. In the last six months, the company's shares have seen an uptick from 1,256.35 on 14 December to Rs 1,606.90 on June 14.
