Hanmi Pharmaceuticals' Cephalosporin antibiotic will be the company's, and the country's, first product to enter the European market.
The company announced on April 29 that it recently received final marketing authorization of its “Triaxone 1g injection” antibiotic powder from four countries in Europe.
This market authorization is acquired by the Federal Institute for Drugs and Medical Devices (BfArM) in Germany, permitting four E.U. countries, including Germany, the U.K., France, and Italy, in accordance with decentralized procedure (DCP).
Hanmi Pharmaceuticals’ Pyeongtaek factory (Managing Director Kim Tae-seo), which produces Triaxone, passed the German Drug Regulatory Authority inspection for good manufacturing practices (GMP) last year, and its endorsement of the E.U. GMP for the complete cephalosporin antibiotic drug product was the very first in Korea.
Through its subsidiary Hanmi Fine Chemical (CEO Yoon Dae-chul), Hanmi Pharmaceuticals has exported the active pharmaceutical ingredients (API) of cephalosporin antibiotics for the last 30 years and secured its market share in the 30s. With this marketing authorization for the complete medicine, the company is hoping to raise the added value of export to Europe.
Starting with the four countries, Hanmi Pharmaceuticals is seeking regulatory approval in more countries and planning to expand to countries allowing domestic marketing, and to export 10 million vials annually in cooperation with leading pharmaceutical firms in Europe. In fact, the company signed a contract last year to export one million vials of Triaxone every year to top pharmaceutical company BASI in Portugal.
An official from Hanmi Pharmaceuticals said, “The E.U. market authorization proves globally the superiority of our technology in complete medicine production, following the raw material medicine of cephalosporin antibiotics. Hanmi will expand its exporting countries throughout Europe in the future, accelerating a market invasion in the global market.”