Biologicals & VaccinesNOC / Conditional
Hepatitis B Vaccine (Recombinant)
Recombinant Hepatitis B Surface Antigen Vaccine
WHO-GMP Partner-Manufactured
Target: Africa, SE Asia
Regulatory-Aware Support
Reliable Supply Chain
Product Overview
A recombinant hepatitis B vaccine supplied to national immunisation programmes and institutional buyers through WHO-GMP certified manufacturing partners with validated cold-chain logistics.
Key Points
- Recombinant DNA technology hepatitis B vaccine
- Cold-chain validated logistics required
- WHO Prequalification status confirmed per manufacturing partner for UN procurement
Quick Specifications
| Generic Name | Recombinant Hepatitis B Surface Antigen Vaccine |
|---|---|
| Dosage Form | Injection (single-dose vial / pre-filled syringe) |
| Strength | 10 mcg / 20 mcg per dose |
| HS Code | 3002 |
| Packaging | Single-dose vials, multi-dose vials on request |
| MOQ | MOQ on request — programme/tender quantities supported |
| Shelf Life | 24–36 months, cold-chain dependent |
| Storage | Store at 2–8°C, do not freeze |
Regulatory Information
Schedule H — Prescription Only
Not retail-dispensed — hospital, clinic and national immunisation programme use. Requires Form 21B and a validated cold chain; WHO Prequalification is confirmed per manufacturer for UNICEF/Gavi procurement. Quoted only against verified institutional or programme buyers.
View Vaccines & Biologicals class detailsRequirements vary by destination. Verify current requirements with the relevant authority before shipment. See our Compliance page.
Request a Quote
Get pricing, MOQ and export details for Hepatitis B Vaccine (Recombinant).
Need documentation first?
Our team can share a product brochure and manufacturing-partner regulatory summary on request — just mention it in your enquiry.