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One of the deficiencies is categorised as ‘major’ and is being addressed in consultation with the regulatory agency, says the company
One of the deficiencies is categorised as ‘major’ and is being addressed in consultation with the regulatory agency, says the company
Biotechnology major Biocon Biologics on Tuesday said Ireland’s health regulator had reported some deficiencies in the manufacturing process at the company’s plant in Bengaluru.
The Health Products Regulatory Authority (HPRA), Ireland, conducted a GMP (Good Manufacturing Practice) inspection of one of Biocon Biologics’ new monoclonal antibody drug substance manufacturing facilities in Biocon Park, Bengaluru, between March 28 and April 1, 2022, a Biocon Biologics spokesperson said in a regulatory filing.
“The inspection report contains no ‘critical’ observations and only one of the deficiencies is categorised as ‘major’ which is being addressed expeditiously in consultation with the regulatory agency,” the spokesperson added.
The facility will help the company address the additional requirements of products in the European Union market, the spokesperson noted.
Biocon Biologics is a subsidiary of Biocon Ltd.
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