Lupin New Jersey facility gets USFDA warning letter
Mumbai: Drug major, Lupin, has recently announced that the company has received a warning letter from the USFDA for its Somerset, New Jersey facility.
The USFDA had inspected the Lupin Somerset site from September 10, 2020 to November 5, 2020.
"We are committed to addressing the concerns raised by the USFDA and will work with the FDA and the New Jersey District to resolve these issues at the earliest," the company said in a filing.
"The company does not believe that the warning letter will have an impact on disruption of supplies or the existing revenues from operations of this facility," it added
Read also: Lupin donates oxygen generation plants to 3 States to assist Covid-19 battle
Lupin Limited is a global pharmaceutical company based in Mumbai, Maharashtra, India.
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.
Read also:Lupin bags USFDA nod for Emtricitabine, Tenofovir Disoproxil Fumarate Tablets to treat HIV
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