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Biocon Biologics new mAbs drug substance facility undergoes HPRAs GMP inspection

4 May 2022 , 08:33 AM

Biocon announced 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 28 March and 01 April 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

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