USFDA closes audit of Zydus' Moraiya facility

Tunia Cherian Updated - January 12, 2018 at 02:32 PM.

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Healthcare player Zydus Cadila (Cadila Healthcare Ltd) on Wednesday informed that it had received an audit report from the US drug regulator, the US Food and Drug Administration (USFDA), for the company's formulations facility at Moraiya near Ahmedabad.

The company said an Establishment Inspection Report (EIR) has been received from USFDA, signifying the successful closure of the audit.

"The Moraiya manufacturing plant had completed the USFDA audit from February 6 to 15, 2017, with Zero 483 observations. Post the audit, the plant has received several product approvals, including final approval to market Mesalamine Delayed-Release Tablets USP, 1.2 g in the US," it said.

The company's shares traded negative at Rs 520.85, down 0.5 per cent on the National Stock Exchange (NSE) on Wednesday.

Published on June 21, 2017 09:30