Natco Pharma receives successful EIR from USFDA for its Telangana unit

Indian pharmaceutical company Natco Pharma Limited has received successful Establishment Inspection Report (EIR) from the US Food and Drug Administration (USFDA) for its Kothur unit in Telangana, which predominantly caters to regulated international markets including the US.


Natco received the EIR from USFDA within a month of getting the final approval of Abbreviated New Drug Application (ANDA) from the US drug regulatory authority for the anti-cancer chemotherapy drug Azacitidine.

The Hyderabad-based pharma company recorded a consolidated total revenue of Rs 2,078.9 crore for the year ended on 31st March, 2017, as against Rs 1,089.7 crore a year earlier — reflecting a year-over-year growth of 90.8 per cent.

The company has this year launched a number of generic products for the Indian and US market including pomalidomide (for treatment of blood cancer) and Sofosbuvir (for treatment of Hepatitis C virus (HCV) infection).


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