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HPRA Completes Audit of Biocon Biologics New mAbs Drug Substance Facility in Bengaluru

  • Thu, 03-Mar-2022
  • Posted by: BIOCON
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Notification to Stock Exchanges

COMPANY STATEMENT

“This is to inform you that the Health Products Regulatory Authority (HPRA), Ireland, conducted a GMP inspection of one of Biocon Biologics’ new monoclonal antibody drug substance manufacturing facilities in Biocon Park, Bengaluru, India, between March 28 and April 1, 2022.

The inspection report contains no ‘critical’ observations and only one of the deficiencies is categorized as ‘major’ which is being addressed expeditiously in consultation with the regulatory agency. This facility will help us address the additional requirements of our products in EU market.”

– Biocon Biologics Spokesperson


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Author: BIOCON

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