USFDA issues warning letter for Lupin's Somerset facility

Lupin said that the company has received a warning letter from the U.S. FDA for the company's Somerset, New Jersey facility.

The U.S. FDA had inspected the Lupin Somerset site from September 10, 2020 to November 5, 2020.

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, Lupin said.

We are committed to addressing the concerns raised by the U.S. FDA and will work with the FDA and the New Jersey District to resolve these issues at the earliest, the company said.

The announcement was made on Sunday, 13 June 2021. Shares of Lupin rose 0.05% to settle at Rs 1,230.25 on Friday, 11 June 2021.

Lupin is an innovation-led transnational pharmaceutical company. 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 Asia Pacific (APAC), Latin America (LATAM), Europe and Middle-East regions.

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