Aarti Drugs clarifies on news item

Sep 26, 2013, 02.28 PM IST

Aarti Drugs Ltd has clarified on the news item appearing in a newspaper titled, FDA issues warning letter to Aarti Drugs.

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Aarti Drugs clarifies on news item

Aarti Drugs Ltd has clarified on the news item appearing in a newspaper titled, FDA issues warning letter to Aarti Drugs.

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Aarti Drugs clarifies on news item

Aarti Drugs Ltd has clarified on the news item appearing in a newspaper titled, FDA issues warning letter to Aarti Drugs.

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With reference to the news item appearing in a newspaper titled "FDA issues warning letter to Aarti Drugs", Aarti Drugs Ltd has clarified to BSE that :"We confirm that our USFDA site at Tarapur had been inspected in Oct'2012. Subsequently, we submitted response to USFDA by Nov-Dec'12. Recently, we have received a warning letter from USFDA pertaining to few of our responses which need to be further corrected.For this we have already submitted an initial response to USFDA. In addition to that, we have already hired a USA based FDA consultant to further review our responses and send another detailed response by 15th Oct'2013. We are putting efforts tofurther enhance the quality systems to avoid such things in future. Aarti Drugs continues to cooperate with FDA to resolve the issues at the earliest."Source : BSE

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