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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



[Hugel announced that the European Medicines Agency completed the on-site inspection of its ¡®Geodu plant¡¯ in Chuncheon on the 18th.

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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