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Cadila Healthcare receives warning letter from US FDA

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The letters were received for its two facilities in Gujarat

Cadila Healthcare has received a warning letter from the US Food and Drug Administration (US FDA) for its two facilities in Gujarat.

“The company has received a warning letter issued by US FDA relating to its Moraiya formulation facility and Ahmedabad API facility (Zyfine) in Gujarat,” Cadila Healthcare said in a BSE filing.

“The company is working hard to ensure that the commitments made to US FDA are fully completed. The company will continue to take all necessary steps to ensure that the US health regulator is fully satisfied with our remediation of the above facilities,” it added.

Cadila Healthcare said there are no products in the US market which use Active Pharmaceutical Ingredient (API) of Zyfine facility.

“We will respond to US FDA to address the observations within the statutory time permitted in the letter. We are committed to resolve all the issues and revamp our quality systems and processes as the top most priority,” the company added.

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