Hepatitis B Vaccine Suppliers & Bulk Manufacturers
Available Forms: Recombinant injectable vaccine (IM injection), Pre-filled syringes
Available Strengths: 10 µg/0.5 mL
Reference Brands: Engerix-B(US)
Category:
Vaccines
Hepatitis B vaccine stimulates the immune system to produce protective antibodies against the hepatitis B virus by introducing non-infectious viral proteins. It prevents infection, reduces the risk of liver cirrhosis and cancer, and provides lifelong immunity, supporting global efforts to control and eliminate hepatitis B.
Hepatitis B Vaccine is available in Recombinant injectable vaccine (IM injection), Pre-filled syringes
and strengths such as 10 µg/0.5 mL.
Sourced from GMP-certified and ISO-compliant manufacturers, this API meets
global pharmacopeia standards (USP/EP/JP as applicable). Ideal for pharmaceutical
formulation and commercial manufacturing, Hepatitis B Vaccine is supplied in
bulk quantities with complete regulatory support including DMF, COA, and MSDS.
|
Technical Specifications & Supply Details
|
| Lead Time |
7 to 60 days (depending on batch size & schedule) |
| MOQ |
As per manufacturer’s batch size |
| COA |
Available with every batch |
| Regulatory Dossier / DMF |
Available upon request |
| Export Documentation |
FSC, COA, Manufacturing License, Product Permission |
| Standards |
IP, BP, USP |
| Certifications |
WHO-GMP, EU-GMP, USFDA (as applicable) |
Hepatitis B Vaccine can be exported to over 30 countries across Asia, Africa, Europe,
and Latin America. Flexible packaging, competitive pricing, and a verified supplier
network make Pharmatradz a trusted sourcing partner for pharmaceutical companies
and contract manufacturers worldwide.
Product Description:
Hepatitis B vaccines are approved in both the US and EU, supported by dossiers demonstrating safety, efficacy, and manufacturing quality per GMP standards. In the US, FDA regulates these vaccines, requiring clinical trial data and safety profiles. In the EU, CE marking certifies conformity with in vitro diagnostic regulations. These vaccines undergo validation, stability assessments, and extensive audits, with comprehensive documentation including safety profiles, clinical efficacy data, and manufacturing details. For licensing procedures, approved dossiers, and the latest regulatory updates, visit Pharmatradz. Ensuring compliance guarantees access to safe, effective hepatitis B immunization products worldwide, vital for disease prevention and public health.
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