Hepatitis B Vaccine bulk supplier for pharma manufacturers

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 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.

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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.

Frequently Asked Questions

Yes, Hepatitis B Vaccine is available with DMF and other regulatory documents such as COA and MSDS. These can be provided upon request for qualified buyers.

Absolutely. Sample requests are accepted for formulation trials and quality checks. Please submit an enquiry to initiate the process.

Our manufacturing partners are GMP-certified and comply with ISO and WHO standards, ensuring global quality benchmarks.

Lead times vary based on quantity and destination, but most orders are fulfilled within 1–3 weeks. Express shipping options are available.

Yes, Hepatitis B Vaccine is exported to over 30 countries across Asia, Africa, Europe, and Latin America. We support documentation for customs and regulatory clearance.

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