The new dosage of the already known drugs "Agemfil A" and "Agemfil B" will expand the possibilities of their use.
Currently, an important stage of registration of the drug "Agemfil A" in a dosage of 500 IU is underway — vials for pharmaceutical expertise have been developed and transferred to the regulator. The documents, which are a 5,000-page dossier, were submitted for registration to the Ministry of Health of the Russian Federation in 2022. After passing all of the registration stages, the production line of the drug "Agemfil A" in a dosage of 500 IU will be launched. A similar procedure is being prepared for the drug "Agemfil B" in a dosage of 500 and 1000 IU. Previously, the drugs were produced only in a dosage of 250 units. The volumes released only covered the need of patients of the NMRC for Hematology. The new dosage will expand the possibilities of using the drug, and the complete reconstruction of the premises will increase the volume of production.
The drugs "Agemfil A" and "Agemfil B" have been produced in the NMRC for Hematology since 2006 and 2002, respectively. The drugs are used for the treatment and prevention of bleeding in patients with hemophilia and for use during surgical interventions.
The preparations contain a concentrate of natural plasma proteins responsible for blood clotting: coagulation factor VIII (for "Agemfil A") and coagulation factor IX (for "Agemfil B"). Their introduction provides an increase in the content of blood clotting factors and temporarily eliminates the defect of hemocoagulation. The preparations are made from donor blood plasma and are a lyophilizate (powder) for the preparation of a solution.
In 2022, a complete reconstruction of the premises was carried out. Equipment and licenses were updated, and raw materials were prepared. Rooms for plasma processing and production of finished dosage forms fully comply with the requirements of Good Manufacturing Practice (GMP) for "clean" rooms. Work will commence as soon as the registration certificate is received.
