Zydus Cadila: USFDA classifies Ankleshwar facility as No Action Indicated

The US Food and Drug Administration (USFDA) had conducted an inspection at the facility from July 22-26, 2019. The EIR report stated that the classification of the facility is "No Action Indicated (NAI)", Zydus Cadila added.

New Delhi: Drug firm Zydus Cadila on Monday said it has received an Establishment Inspection Report from the US health regulator for its manufacturing facility located at Ankleshwar in Gujarat.

The company's active pharmaceutical ingredient (API) manufacturing facility located at Ankleshwar (unit 1), Gujarat has received an Establishment Inspection Report (EIR), Zydus Cadila said in a regulatory filing.

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The US Food and Drug Administration (USFDA) had conducted an inspection at the facility from July 22-26, 2019. The EIR report stated that the classification of the facility is "No Action Indicated (NAI)", the company added.

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.

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