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 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.
The shares of Lupin Ltd were trading at Rs 851.70 a piece on BSE in morning trade, up 3.12 per cent from the previous close.
