The UK's SGS authority has granted CE mark certification to Hanmi Pharmaceutical's Hyalrheuma injectable viscosupplement.
Since October 2010, SGS inspected and audited Hanmi Pharm’s PyeongTaek Bio plant, the site responsible for the production of sodium hyaluronate raw material used in manufacturing Hyalrheuma.
The CE mark certification allows Hanmi to distribute and manufacture Hyalrheuma as a medical device in Europe.
Hanmi said in Korea Hyalrheuma is classified as a specialised medication, while in Europe it is now classified as a medical device of Class 3.
Hanmi is in negotiations with the European companies to export its Hyalrheuma by the middle of the second quarter.