Corporate Announcement
Security Code : 532612    Company : INDOCO    
 
Clarification 
  Exchange Disseminated Time     
With reference to the volatility in share price of the Company, Indoco Remedies Ltd has clarified to BSE as under :

"The Goa Plant II (Sterile) was first inspected in October 2005, re-inspected in February 2011 and the last inspection was conducted in August 2013 by USFDA. On the last day of inspection, i.e. August 30, 2013, the 483 was issued which is a subject matter of news currently doing the rounds.

In our response, on September 16 to the 483s, we have given list of the corrective actions taken and the proposed actions with completion timelines to address the issues raised in the 483.

Subsequently as the Corrective Actions and Preventive Actions (CAPAs) were executed, updated reports with proof of compliance were sent for USFDA's perusal on October 23, 2013 and November 25, 2013. With the last compliance report sent on November 25, 2013, all the issues stand resolved and the Company is awaiting establishment inspection report (EIR), which normally takes 5-6 months time.

The Company has not received any Warning letter from USFDA and were wish to inform you that no fresh development has taken place and that the Company is waiting the final approval from the USFDA"
 

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