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Ireland regulator reports manufacturing deficiency at Biocon's plant

Biocon Biologics is a subsidiary of Biocon Ltd

Biocon | Ireland | Bengaluru

Press Trust of India  |  New Delhi 

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major Biologics on Tuesday said Ireland's health regulator has reported some deficiencies in the manufacturing process at the company's plant in .

The Health Products Regulatory Authority (HPRA), Ireland, conducted a GMP (Good Manufacturing Practice) inspection of one of Biologics' new monoclonal antibody drug substance manufacturing facilities in 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.

(Only the headline and picture of this report may have been reworked by the Business Standard staff; the rest of the content is auto-generated from a syndicated feed.)

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First Published: Wed, May 04 2022. 01:59 IST