Natco Pharma Mekaguda facility gets EIR from USFDA

Published On 2019-10-01 10:27 GMT   |   Update On 2021-08-16 06:08 GMT

Hyderabad: Drug firm Natco Pharma today said it has received Establishment Inspection Report (EIR) from the US health regulator for its Active Pharmaceutical Ingredient (API) facility in Mekaguda Village, near Hyderabad.


The US Food and Drug Administration (USFDA) conducted the inspection of the facility from August 5, 2019, till August 9 2019.


"Natco Pharma Limited is pleased to announce successful closure of inspection with the receipt of an Establishment Inspection Report (EIR) from the U.S. Food and Drug Administration (FDA) for the inspection conducted at its Active Pharmaceutical Ingredient (API) facility in Mekaguda Village, near Hyderabad, India, " Natco said in a filing.


Also Read: Delhi HC given Green Signal to Natco Pharma for generic of Novartis cancer drug Ceritinib


The USFDA gives EIR on the closure of inspection of an establishment that is the subject of an FDA or FDA-contracted inspection.






Natco Pharma is engaged in developing, manufacturing and marketing finished dosage formulations (FDF) and active pharmaceutical ingredients (APIs).



Also Read: Natco Pharma gets 6 USFDA observations for API facility near Hyderabad

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