Lupin's Mandideep Unit II facility receives EIR from USFDA

Pharma major Lupin on Wednesday said it has received an establishment inspection report (EIR) from the US health regulator for its Mandideep Unit II facility in Madhya Pradesh. The inspection at the facility was carried out by the US Food and Drug Administration between November 26, 2018, and December 4, 2018.

In a filing to BSE, the company said Lupin has received the EIR after the closure of the USFDA inspection of its Mandideep Unit II facility, classifying the inspection as "Voluntary Action Indicated."

"We are pleased to have received the EIR for our Mandideep Unit II facility, our important cardiovascular active pharmaceutical ingredients (API) manufacturing facility," Lupin Managing Director Nilesh Gupta said.

The company develops and commercialises a wide range of branded and generic formulations, biotechnology products and APIs in over 100 markets in the US, India, South Africa and across Asia Pacific, Latin America, Europe and Middle-East regions.