29.12.2023
The NMRC for Hematology of the Ministry of Health of Russia has expanded the registration certificate for new dosages of the drug "Agemfil A.” Industrial production of the drug in dosages of 500 IU and 1000 IU has begun.
The Experimental and Production Division of Advanced Plasma Processing of the NMRC for Hematology develops and manufactures medicines from components of donated blood in accordance with the license of the Ministry of Industry and Trade of the Russian Federation, updated in 2021.The production process in the division includes the production of the following medicines:
- Plasma for fractionation
- "Agemfil A", lyophilizate for the preparation of solution for infusions, 250, 500, 1000 IU
The drug "Agemfil A" (500 and 1000 IU) is certified by the Chamber of Commerce of the Russian Federation in the form of CT-1, which means that the drug is made from Russian raw materials at Russian production facilities. This ensures independence from the supply of imported analogues.
"Agemfil A" provides an increase in the content of blood clotting factors and temporarily eliminates the defect of hemocoagulation in hemophilia A. The drug is included in the list of vital and essential medicines. The production technology of "Agemfil A" is patented by the NMRC for Hematology of the Ministry of Health of Russia. Rooms for plasma processing and production of finished dosage forms fully comply with the requirements of Good Manufacturing Practice (GMP) for "clean" rooms.” New dosages will expand the possibilities of using the drug. Previously, the drug was available only in a dosage of 250 IU.
