Lupin's Mandideep unit receives US FDA observations

Lupin's Mandideep unit has been flagged by United States Food and Drug Administration (US FDA). In particular, the active pharmaceutical ingredient (API) and formulations units of the plant in Madhya Pradesh have received two observations each, reports CNBC-TV18. The pharma company's Mandideep unit was inspected by US FDA between February 8-19.   IIFL says these are very serious observations, adding the company may take at least 18 months to complete remedial action. Estimates suggest the Mandideep unit could be contributing USD 200 million in revenues for Lupin. The unit is the second largest revenue contributor to the company's US business after its Goa plant. 

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