Lupin gets EIR from USFDA for its Vishakhapatnam facility

Lupin Limited has received an establishment inspection report (EIR) from United States Food & Drug Administration (USFDA) for its Visakhapatnam (Andhra Pradesh) facility.

The inspection for the API facility was conducted by USFDA between January 13 and January 17, 2020. Earlier in the month of January, after the completion of the inspection, USFDA had issued five observations under form 483 for the above-said facility.

This facility is dedicated towards manufacturing of both non-oncology and oncology APIs. Overall, Lupin’s manufacturing footprint comprises of 18 manufacturing sites spread over India, United States, Japan, Brazil and Mexico.

Last week, the company was successful in closing out the inspection carried out by Medicines and Healthcare products Regulatory Agency (MHRA), which is the regulatory agency of United Kingdom (UK), at its three manufacturing units in Pithampur (Madhya Pradesh).

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

On Thursday, in the early morning session, the stock of Lupin surged 1.7 per cent to Rs 854 from its previous close of Rs 839.75.