US FDA issues warning letter for Lupin’s Mandideep facility

Mumbai: The US Food and Drug Administration (US FDA) has issued a warning letter to pharma major Lupin Ltd for its facility at Mandideep in Madhya Pradesh.

“We wish to inform you that the company has received a warning letter from the US FDA for its Mandideep (unit one) facility,” it informed stock exchanges in regulatory filings on Thursday.

Lupin said this is subsequent to an earlier intimation received from the US FDA in March when the agency had classified its inspection conducted at the same facility in December last year as ‘official action indicated.’

However, there are no drug master file (DMF) and abbreviated new drug application (ANDA) pending review or approval from the Mandideep unit one facility. “The company does not believe that the warning letter will have an impact on disruption of supplies or the existing revenues from operations of this facility,” it said.

Lupin said it is committed to addressing the concerns raised by US FDA and will work with to resolve the issues at the earliest. “We uphold quality and compliance issues with utmost importance and remain committed to be compliant with current good manufacturing practice (CGMP) quality standards across all our facilities.”

Lupin is the eighth largest generics pharmaceutical company by revenues globally. Its 18 manufacturing facilities are spread across India, Japan, the United States, Mexico, and Brazil.

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