Batch release certificate
CoA per batch
2–8 °C validated
Plasma-Derived
Exported
GMP approved
Human Immunoglobulin for Intravenous Injection
静注人免疫球蛋白 · 2.5 g / 50 ml (5%) · 5 g / 100 ml
Polyclonal human immunoglobulin for intravenous administration, 5% solution in single-dose vials.
Overseas registration
BrazilExported 2020–2021, approx. USD 25 m
Registered
TürkiyeGMP certificate issued 2021
GMP approved
PhilippinesGMP waiver issued 2021
GMP approved
This product is supplied by China Resources Boya 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.
▤Türkiye GMP certificate
▤Philippines GMP waiver
▤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.