Lupin gets Establishment Inspection Report from FDA for Aurangabad facility

Topics Lupin Pharma | USFDA | Pharma sector

Drug firm Lupin on Monday said it has received an Establishment Inspection Report (EIR) from the US health regulator for its Aurangabad facility in Maharashtra.

The facility was inspected by the US Food and Drug Administration (USFDA) between May 6-15, 2019, Lupin said in a BSE filing.

Lupin said its Aurangabad facility is involved in the manufacturing of oral solid dosage, oral liquid and powder for oral suspension products for the US Market, WHO/Global Institution markets and Indian market.

"Lupin is committed to adherence and full compliance with current good manufacturing practice (cGMP) regulations and all other applicable regulatory requirements at our manufacturing sites. We are very happy to receive the EIR for our Aurangabad facility marking the satisfactory closure of the USFDA inspection," Lupin Managing Director Nilesh Gupta said.

The USFDA issues an EIR to an establishment that is the subject of an FDA or FDA-contracted inspection when the agency decides to close the inspection.

Lupin's shares were trading 1.05 per cent lower at Rs 757.75 apiece on the BSE.



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