human hepatitis b immunoglobulin Injection 100 IU/0.5 ml, 200 IU/10 ml, 2000 IU/10 ml

Dossier type
CTD
Dossier status
Ready to file
Country of origin
South Korea
GMP approvals
PICS
Manufacturer #35085

Established in 1967, this South Korean manufacturer specializes in the development and commercialization of vaccines, protein therapies, and therapeutic antibodies for oncology and infectious diseases. As a CTD dossier owner and manufacturer, it holds GMP certifications from international regulatory authorities, ensuring compliance with stringent quality standards. The manufacturer operates advanced production lines adhering to rigorous GMP guidelines. As a CTD dossier owner and manufacturer, its products are distributed in more than 50 countries worldwide. With a focus on innovation and quality, the manufacturer is committed to delivering high-standard pharmaceutical solutions to enhance patient care.

 

Manufacturer usually replies in 114 days

Human Hepatitis B Immunoglobulin Manufacturers

Human Hepatitis B Immunoglobulin is available under the brand names Hepagam B, Hyperhep B, and Nabi-HB. It is classified as Protein Based Therapies or Polyclonal antibodies. It is indicated for the treatment of viral hepatitis B and liver transplant surgery. This pharmaceutical medicine is administered through the intravenous route in the form of a solution and is available in the strengths 200 IU and 500 IU. Common side effects associated with this drug include nausea, vomiting, back pain, tiredness, memory problems, cold symptoms, tremors, vision problems, and agitation. Its safety during human pregnancy is not yet established as it can cross the placenta, especially during the third trimester. It should be used by lactating women with utmost caution due to its safety profile. This pharmaceutical medicine is known to have drug interactions with Anthrax immune globulin human, Antilymphocyte immunoglobulin (horse), Alemtuzumab, and Abiciximab among many others. This drug is contraindicated in patients having hypersensitivity towards this globulin, IgA deficiency, and coagulopathy. It was approved by the FDA on January 30, 2006, under the brand name Hepagam B, manufactured by Cangene Company.

How does Human Hepatitis B Immunoglobulin work?

Its exact working mechanism is unknown, but it may work by blocking HBV entry and its binding to hepatocytes and targeting infected cells by an antibody-mediated response.

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