The United States Food & Drugs Administration (USFDA) has begun inspecting Lupin's unit at Mandideep on Tuesday, sources have exclusively told CNBC-TV18.
A warning letter was issued to the said unit by the US drug regulator in 2019. Unit II of the said unit had received an Establishment Inspection Report (EIR) from the USFDA in April 2020. Lupin has been plagued with USFDA issues in the recent past. However, the Mandideep plant audit inspection could be a re-audit by the US regulator after the company filed a compliance report.
The company, which received a USFDA warning letter on its active pharmaceutical ingredient (API) facility at Tarapur, and also certain negative observations on its biotech plant in Pune (both in Maharashtra) early November, did not offer a comment to CNBC-TV18's queries regarding the Mandideep plant inspection.
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"We are obviously disappointed with the warning letter for Tarapur," Nilesh Gupta said earlier, adding that they have put a very solid plan in place and that the company would have covered a lot of ground within the next 3-4 months to go back to the FDA.
Lupin 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.
Shares of Lupin are trading 1.2 percent lower at Rs 750.60.
First Published: Nov 15, 2022 12:46 PM IST
