Corporate Announcement
Security Code : 532523    Company : BIOCON    
 
Pre -Approval U.S. FDA Inspection Conducted At Biocon'S Insulins Facilities In Malaysia
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  Exchange Received Time  08/07/2019 08:10:32         Exchange Disseminated Time   08/07/2019 08:10:34              Time Taken   00:00:02
'This is to inform you that Biocon Sdn Bhd's Insulin Glargine Drug Substance, Drug Product and Device assembly facilities in Malaysia underwent a pre-approval inspection by the U.S. FDA between June 24 and July 5, 2019. The inspection across these 3 units concluded with 12 observations issued on the Form 483.

We will respond to the FDA with a Corrective and Preventive Action Plan and are confident of addressing these observations expeditiously. We do not expect any change to our commercialization plans for Insulin glargine in the U.S. Biocon remains committed to global standards of Quality and Compliance.'
- Company Spokesperson
 

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