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Lupin receives EIR report from USFDA for Goa plant


Lupin receives EIR report from USFDA for Goa plant

New Delhi :  Drug major Lupin today said it has received Establishment Inspection Report (EIR) from the US health regulator for its Goa plant leading to closure of all outstanding inspections of the facility.

The company said it has received notification that the inspection carried out by the USFDA in March 2016 at its Goa facility is now closed and the agency has issued an Establishment Inspection Report (EIR).

“This closes all outstanding USFDA inspections at Lupins Goa facility, the company said in a statement. Commenting on the receipt of the EIR, Vinita Gupta, Chief Executive Officer and Nilesh Gupta, Managing Director, Lupin said the company is committed to ensuring that all systems and processes followed are compliant with cGMP and are committed to bringing quality products to market. “We are grateful for the USFDAs confidence in our corrective action plan and in our team. It is our goal to remain well ahead on the compliance curve,” they added. USFDA releases a copy of the EIR to the establishment that was the subject of an FDA or FDA-contracted inspection when the agency determines the inspection to be closed. The companys Goa facility supplies over 100 products to various regulated markets including the US and EU. The plant has filed more than 115 abbreviated new drug applications (ANDAs) in the US market.



Source: PTI
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