Natco Pharma gets zero USFDA observations for Chennai facility

Natco Pharma announced "successful completion of regulatory inspection from the US Food and Drug Administration (USFDA) for its active pharmaceutical ingredient (API) facility in Chennai, India, conducted during the period July 8-12, 2019".

New Delhi: Natco Pharma Monday said the US health regulator has completed the inspection of its Chennai facility, and it ended with zero observations.

In a regulatory filing, Natco Pharma announced "successful completion of regulatory inspection from the US Food and Drug Administration (USFDA) for its active pharmaceutical ingredient (API) facility in Chennai, India, conducted during the period July 8-12, 2019".

"The regulatory audit resulted in zero observations," the company added.

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A month ago Natco had received another 9 USFDA observations for its Kothur facility. Medical Dialogues had earlier reported that Natco Pharma told that the US health regulator had made nine observations after the completion of inspection of its Kothur formulation facility in Telangana.

The root of the company goes back to the founding of NATCO (Acronym for National Trading Company) Pharmaceutical Division in Kothur, Telangana.

Also Read: Natco Pharma- Kothur facility gets 9 observations from USFDA