Cadila Healthcare gets EIR from USFDA for Moraiya facility

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New Delhi | Published: July 8, 2016 6:16:00 PM

Though this is a positive step towards the resolution of the warning letter issued by the USFDA, it does not in itself indicate resolution of the warning letter, it added.

This receipt of EIR only indicates closure of the inspection points (483s) raised based on the inspection carried out between August 28, 2014 and September 05, 2014, it added. ( Source: Reuters)This receipt of EIR only indicates closure of the inspection points (483s) raised based on the inspection carried out between August 28, 2014 and September 05, 2014, it added. ( Source: Reuters)

Drug firm Cadila Healthcare has received Establishment Inspection Report (EIR) from the US health regulator for its manufacturing facility in Moraiya, indicating “closure of the inspection points” of initial review in 2014.

The company’s “Moraiya manufacturing facility has received an Establishment Inspection Report from the United States Food and Drug Administration (USFDA),” Cadila Healthcare said in a filing to BSE.

This receipt of EIR only indicates closure of the inspection points (483s) raised based on the inspection carried out between August 28, 2014 and September 05, 2014, it added.

“What is ‘closed’ is the initial review that resulted in the warning letter issuance,” Cadila Healthcare said.

Though this is a positive step towards the resolution of the warning letter issued by the USFDA, it does not in itself indicate resolution of the warning letter, it added.

Emphasising that it is taking steps for the resolution of the issues raised in the warning letter, Cadila said: “The company is in constant follow up with the USFDA for resolution of the warning letter.”

Cadila stock closed 4.81 per cent up at Rs 359.30 on BSE.

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