Unibest

Human Immunoglobulin (pH4) for Intravenous Injection

Formulation (FDF) · Injection · 1.25g/vial (5%, 25mL); 2.5g/vial (5%, 50mL); 5g/vial (5%, 100mL)

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Formulation (FDF)Confidentiality:Public
INN / Generic Name
Human Immunoglobulin (pH4) for Intravenous Injection
Dosage Form
Injection
Strength
1.25g/vial (5%, 25mL); 2.5g/vial (5%, 50mL); 5g/vial (5%, 100mL)
Therapy Area
Immunology & Inflammation
Indication
Primary immunodeficiency; Secondary immunodeficiency; Autoimmune disorder
Current Status
Official FDF licensing catalog (UB128)
GMP Certification
CN - NMPA
CEP
No
DMF Type
—
Stability Data
—
BE Required
Not required / waivable
Registration Pathway
Registered (market rights transferable / DCP·NP per market)
MOQ
On request
Lead Time
On request
Price Range
On request
HS Code
3002.15
Registrable Markets
To be assessed

Process / Sequence / Exact Price

Process Summary
—
Exact Price