Huons Biopharma's 2nd Plant Producing 'Hutox' Receives EU GMP Certification

Huons Biopharma announced on the 7th that its second production plant for the botulinum toxin (BTX) formulation 'Hutox' (domestic product name Riztox) has received the European Medicines Quality Standard (EU GMP) certification from the Brandenburg State Office for Consumer Protection and Food Safety (LAVG) in Germany.

Huons Biopharma's botulinum toxin preparation 'Hutox Injection 100 Units'.
[Photo by Huons Biopharma]

Huons Biopharma obtained the EU GMP certification following an on-site inspection by LAVG conducted in October last year.

Huons Biopharma has completed preparations for entering the European market, including signing an exclusive export contract for Hutox in Europe with the German pharmaceutical company HAEMATO PHARM GmbH in October 2021.

With this EU GMP approval, Hutox plans to accelerate exports to Europe. Since Huons Biopharma has successfully completed clinical trials for glabellar line improvement domestically, it expects a smooth entry into the European market. Additionally, it plans to speed up local approvals and clinical trials overseas, starting with ongoing clinical trials in China and Taiwan.

A Huons Biopharma official stated, "Based on this EU GMP approval, following exports to 10 countries including Russia, Ecuador, Uzbekistan, Kazakhstan, Bolivia, Iraq, Azerbaijan, the Dominican Republic, Georgia, and Armenia, we will focus on pioneering emerging markets such as Europe, the United States, China, and Southeast Asia. We will continuously raise product awareness and strengthen our position in the global market."

Meanwhile, Hutox offers three lineups of 50, 100, and 200 units and has obtained indications for improving glabellar lines and lateral canthal lines domestically.

This content was produced with the assistance of AI translation services.