Humedics "Application for Heparin Sodium Raw Material Drug Registration with MFDS"

[Asia Economy Reporter Lee Gwan-joo] Humedix announced on the 6th that it has completed the application to the Ministry of Food and Drug Safety for the registration (DMF) of heparin sodium as an active pharmaceutical ingredient.

Heparin sodium is a nationally essential medicine used for the prevention and treatment of thrombosis after surgery, blood transfusion, extracorporeal circulation, and dialysis to prevent blood coagulation. It is listed as one of the three major medicines prescribed for blood coagulation, along with enoxaparin and warfarin, on the World Health Organization (WHO) Essential Medicines List.

Heparin sodium is extracted, purified, and processed from the intestines of pigs. The U.S. Food and Drug Administration (FDA) prohibits the use of ruminants such as cattle in the production of heparin sodium due to concerns about contamination with bovine spongiform encephalopathy or oversulfated chondroitin sulfate (OSCS).

Globally, about 90% of heparin sodium depends on China, and recently, the outbreak of African swine fever in China and other regions has worsened the supply of raw materials, causing price volatility to surge. In Korea, all raw materials are imported from China and used in finished pharmaceutical products such as injections or ointments.

Humedix has the technology and facilities to produce the main raw material of heparin sodium domestically, uniquely sourcing raw materials from Wooree B&B. A Humedix official stated, “We will lead the first domestic production of heparin sodium, which has so far depended on China, and supply it stably within the country. In addition to existing HA and PDRN raw materials, we plan to develop and produce heparin sodium active pharmaceutical ingredients and introduce them to the global raw material pharmaceutical market.”

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