Cadila Healthcare's Moraiya plant receives USFDA warning letter

The US Food and Drug Administration (USFDA) has sent a warning letter to Cadila Healthcare in relation to its Moraiya formulation facility in Ahmedabad. In a stock exchange filing on Monday, the company claimed that it has taken multiple steps after the inspection to address the observations received from USFDA during the inspection.

"The company will continue to take all necessary steps to ensure that the US FDA is fully satisfied with our remediation of the above facility. We are confident of responding to US FDA to address the observations within the statutory time permitted in the letter," Cadila Healthcare, a unit of Zydus Cadila, said in its statement.

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The USFDA warning letter will not affect the existing business of Cadila Healthcare in the US and the existing product supplies from the Moraiya facility will continue, the company further added.

"Zydus remains committed to patient safety and meeting the expectations of regulatory compliances. After the inspection of Mbraiya facility, Zydus Cadila has successfully completed USFDA audits of formulations manufacturing facility at Baddi, and API manufacturing facilities at Ankleshwar and Dabhasa during the year," the company further stated.

Meanwhile, Cadila Healthcare shares slipped 13.85 points, or 5.42 per cent, to close on 241.45 on BSE Sensex.

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