Octapharma USA
Octapharma USA is a leading healthcare company dedicated to providing innovative health solutions that advance human life. As the largest privately owned plasma fractionator globally, Octapharma develops and manufactures high-quality human proteins sourced from human plasma and cell lines, focusing on hematology, immunotherapy, and critical care. The company is committed to patient engagement and community support, ensuring that their products meet the highest safety and quality standards.
Industries
Nr. of Employees
small (1-50)
Products
Albumin (Human) 5%, 20% and 25% solution
Human albumin solutions for volume replacement and critical care indications.
Prothrombin complex concentrate (4‑factor PCC)
Four‑factor prothrombin complex concentrate indicated for urgent reversal of vitamin K antagonist (warfarin)‑induced coagulopathy in adults requiring urgent surgery or invasive procedures.
Subcutaneous immune globulin 16.5% solution
Immune globulin for subcutaneous administration used in immunotherapy indications such as primary immunodeficiency.
Fibrinogen concentrate (lyophilized)
Virus‑inactivated human fibrinogen concentrate in lyophilized form for reconstitution, indicated for fibrinogen supplementation in acquired fibrinogen deficiency and congenital fibrinogen deficiency.
Recombinant antihemophilic factor (recombinant FVIII)
Recombinant Factor VIII product developed for treatment and prophylaxis in Hemophilia A.
Intravenous immune globulin (IVIG) liquid preparations
Intravenous immunoglobulin liquid preparations in multiple concentrations for immunotherapy indications.
Albumin (Human) 5%, 20% and 25% solution
Human albumin solutions for volume replacement and critical care indications.
Prothrombin complex concentrate (4‑factor PCC)
Four‑factor prothrombin complex concentrate indicated for urgent reversal of vitamin K antagonist (warfarin)‑induced coagulopathy in adults requiring urgent surgery or invasive procedures.
Subcutaneous immune globulin 16.5% solution
Immune globulin for subcutaneous administration used in immunotherapy indications such as primary immunodeficiency.
Fibrinogen concentrate (lyophilized)
Virus‑inactivated human fibrinogen concentrate in lyophilized form for reconstitution, indicated for fibrinogen supplementation in acquired fibrinogen deficiency and congenital fibrinogen deficiency.
Recombinant antihemophilic factor (recombinant FVIII)
Recombinant Factor VIII product developed for treatment and prophylaxis in Hemophilia A.
Intravenous immune globulin (IVIG) liquid preparations
Intravenous immunoglobulin liquid preparations in multiple concentrations for immunotherapy indications.
Services
Collection, testing and supply of human plasma from donation centers for manufacture into plasma‑derived therapies.
Full manufacturing services for plasma‑derived and recombinant human protein medicines, including fractionation, purification, virus inactivation and aseptic filling.
Design, conduct and management of preclinical and clinical studies, trial registration and life‑cycle management support for marketed products.
Analytical testing of donations, intermediates and final products, internal review and external OMCL testing for batch release.
Preparation and management of regulatory dossiers, emergency use authorization requests and orphan designation interactions with regulatory bodies.
Sponsorship and support for patient organisations, educational resources and event participation to support disease communities.
Collection, testing and supply of human plasma from donation centers for manufacture into plasma‑derived therapies.
Full manufacturing services for plasma‑derived and recombinant human protein medicines, including fractionation, purification, virus inactivation and aseptic filling.
Design, conduct and management of preclinical and clinical studies, trial registration and life‑cycle management support for marketed products.
Analytical testing of donations, intermediates and final products, internal review and external OMCL testing for batch release.
Preparation and management of regulatory dossiers, emergency use authorization requests and orphan designation interactions with regulatory bodies.
Sponsorship and support for patient organisations, educational resources and event participation to support disease communities.
Expertise Areas
- Plasma fractionation and plasma‑derived therapeutics
- Biologics manufacturing (plasma‑derived and recombinant proteins)
- Clinical trial management and clinical development
- Viral safety validation and pathogen inactivation
Key Technologies
- Nucleic acid amplification testing (NAT)
- Solvent/detergent virus inactivation
- Nanofiltration for pathogen removal
- Low‑pH virus inactivation
News & Updates
Octapharma USA received FDA Emergency Use Authorization for octaplasLG Powder, allowing U.S. military medical providers to use it in emergencies for hemorrhage or coagulopathy.
JAMA Network Open published study results demonstrating the efficacy and safety of Balfaxar® for warfarin reversal in urgent surgery and invasive procedures.
FDA approved an additional indication for Fibryga® for fibrinogen supplementation in bleeding patients with acquired fibrinogen deficiency.
FDA granted orphan drug exclusivity to wilate®, the first VWF concentrate for prophylaxis in all types of VWD.
Octapharma USA received FDA Emergency Use Authorization for octaplasLG Powder, allowing U.S. military medical providers to use it in emergencies for hemorrhage or coagulopathy.
JAMA Network Open published study results demonstrating the efficacy and safety of Balfaxar® for warfarin reversal in urgent surgery and invasive procedures.
FDA approved an additional indication for Fibryga® for fibrinogen supplementation in bleeding patients with acquired fibrinogen deficiency.
FDA granted orphan drug exclusivity to wilate®, the first VWF concentrate for prophylaxis in all types of VWD.