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