Hugel¡¯s Geodu BTX plant completes EMA inspection
By Lee, Seok-Jun | translator Kang, Shin-Kook
21.10.19 05:45:44
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EMA inspects whether Hugel¡¯s manufacturing facility meets EU-GMP standards from 12-14th
The Geodu plant has a fully automated state-of-the-art system that can manufacture over five million botulinum toxin vials a year.
EMA conducted an on-site inspection on the Geodu plant¡¯s manufacturing facilities and quality control system for 3 days, from the 12th to the 14th, to verify whether the facility complies with the EU-GMP standards.
With the on-site inspection complete, the company expects to acquire the EU GMP certification soon. The company had previously completed FDA¡¯s on-site inspection for cGMP in August.
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Lee, Seok-Jun(wiviwivi@dailypharm.com)
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