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| Exchange Disseminated Time 31/12/2015 10:21:53 | Cadila Healthcare Ltd has informed BSE that :
"The Company has received a Warning Letter issued by the US FDA relating to its Moraiya formulation facility and Ahmedabad API facility (Zyfine).
We take quality and compliance matters very seriously and stand by our commitment to fully comply with cGMP quality standards across all our facilities. The Company is working hard to ensure that the commitments made to the US FDA are fully completed. The Company will continue to take all necessary steps to ensure that the US FDA is fully satisfied with our remediation of the above facilities. We further state that our products in the market are safe and effective and we are committed to supply the quality products to our customers across the globe.
We hereby clarify that there are no products in the US market which use 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." |
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