Batch release certificate
CoA per batch
2–8 °C validated
Plasma-Derived
Human Immunoglobulin for Intravenous Injection (pH4)
静注人免疫球蛋白（pH4） · 2.5 g / 50 ml (5%)
pH 4-stabilised intravenous immunoglobulin, 5% solution in 50 ml single-dose vials.
Overseas registration
No filing yetJoint filing with the appointed partner
This product is supplied by Bohui Innovation under wanyoda's authorised export mandate. Export to markets outside China is coordinated exclusively through wanyoda.
Territories
Where this product is open
Territories listed below have no appointed partner for this product. Appointed markets are shown for transparency and accept secondary-distribution enquiries only.
Documentation
Files released with every shipment
The registration dossier is released to qualified partners once an NDA is signed. Batch-level documents travel with each consignment.
▤GMP certificate
▤Certificate of Analysis
▤Batch release certificate
▤Viral safety study summary
▤English SPC / PIL
Sample documents available on request. Certificates of analysis are issued per batch and are not interchangeable between lots.