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Hepatitis B Vaccine bulk supplier for pharma manufacturers

Hepatitis B Vaccine 10 µg/0.5 mL 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.

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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.

Hepatitis B Vaccine — third party manufacturing & bulk supply

Hepatitis B Vaccine 10 µg/0.5 mL is available through PharmaTradz for wholesale and bulk supply as well as on a third party (contract) manufacturing basis. Buyers sourcing this product generally take one of three routes:

Wholesale / bulk supply Stock or scheduled supply from an existing manufacturer. The fastest route where the product is already registered in your market.
Third party manufacturing Manufactured to your specification and packed under your own brand and label — suits distributors and brand owners building a portfolio in their market.
Dossier licensing Where a CTD, EU-CTD or ACTD dossier exists it can often be licensed for filing in your name, compressing market entry from years to months.

Indicative minimum order quantity

Hepatitis B Vaccine is supplied as Recombinant injectable vaccine (IM injection), Pre-filled syringes — an injectable dosage form, so the indicative MOQ is 50,000 units. Actual MOQ is confirmed by the allocated manufacturer against your pack presentation and destination market. See full supply terms for dossier formats, market availability and shelf life.

Manufacturers of Hepatitis B Vaccine listed on PharmaTradz hold site-level approvals across WHO-GMP, EU-GMP, USFDA, ANVISA and TGA, verified at onboarding.

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Frequently Asked Questions

Hepatitis B Vaccine is listed as Recombinant injectable vaccine (IM injection), Pre-filled syringes in 10 µg/0.5 mL. Further strengths and pack presentations are confirmed with the manufacturer at RFQ stage.

Hepatitis B Vaccine is referenced against Engerix-B(US). Reference brands are shown for identification only and remain the property of their respective trademark owners.

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