Medicine
Bivigam 10 g/100 mL injection
Bivigam 10 g/100 mL injection is a prescription medicine containing Human immunoglobulin g for intravenous use, marketed by ADMA Biologics, with its source record on the US FDA register. It is available on request for export supply from India to licensed hospitals, importers and physicians. It ships in a temperature-controlled cold chain.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Cold chain
Store at 2 to 8°C (36 to 46°F) for up to 36 months from date of manufacture…
Key facts
- Active ingredient (INN)
- Human immunoglobulin g
- Brand
- Bivigam
- Strength
- 10 g/100 mL
- Dosage form
- Injection
- Route
- Intravenous
- Packs
- 1 vial of 100 mL
- Marketing authorisation holder
- ADMA Biologics
- Manufacturer
- ADMA Biologics
- Origin register
- US FDA, United States
- Storage
- Store at 2 to 8°C (36 to 46°F) for up to 36 months from date of manufacture. Do not freeze. Special Precautions for Storage Do not freeze or heat. Allow refrigerated product to come to room temperature before use. Product may be stored up to 4 weeks at ≤ 25°C (77°C). After storage at room temperature product must be used or discarded.
- Cold chain
- Yes, shipped temperature controlled
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- J06BA02 Human immunoglobulin g
- HS code (indicative)
- 3002.12Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 21 January 2013
- Identifiers
- RxCUI 1809414, 1809416, 1809421 +1DailyMed set ID a2244aa0-a6d0-11df-b385-0002a5d5c51bNDC 69800-6503Application BLA125389
Record updated 12 November 2026
Documents available
Documents that can be provided with this medicine. Your regulator may ask for more, and the quote lists the full set.
No document list is recorded for this medicine yet. Tell us which documents your regulator needs (for example a CoA, COPP or GMP certificate) when you request a quote.
Packs
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 1 vial, single-use in 1 carton / 100 mL in 1 vial, single-use | 69800-6503-1 | ADMA Biologics | 21 January 2013 |
Status by register
Where this medicine is registered, from the source record and the regulator data we hold. Ask us about a country that is not listed.
| Register | Status | Source |
|---|---|---|
| US FDA | Listed, marketed | Source record for this pageChecked 12 November 2026 |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Import route
Pick the destination country to see the legal import route, who applies and typical timelines, from our import guide for that country.
Import guides are available for 25 countries. Pick one to see its route summary.
BrazilColombiaEgyptEthiopiaGhanaIraqKazakhstanKenyaAll import guides
Alternatives
Other makers and brands of Human immunoglobulin g 10 g/100 mL injection.
- Yimmugo 10 g/100 mL injectionAvailable on requestBiotestUS FDA2 packs Cold chain
- Gammaked 10 g/100 mL injectionAvailable on requestKedrion BiopharmaUS FDA1 pack
- Gammaplex 10 g/100 mL injectionAvailable on requestBio Products LaboratoryUS FDA1 pack
- Gamunex-C 10 g/100 mL injectionAvailable on requestGrifolsUS FDA1 pack
- Gamunex-C 10 g/100 mL injectionAvailable on requestGrifolsUS FDA1 pack
- Privigen 10 g/100 mL injectionAvailable on requestCSL BehringUS FDA1 pack
Other strengths and forms of Human immunoglobulin g
Clinical summary
Human immunoglobulin g is a human immunoglobulin G indicated for the treatment of adults and pediatric patients 2 years of age and older with primary humoral immunodeficiency (PI). MedsAcross supplies Human immunoglobulin g for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
Read about Human immunoglobulin gFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- BIVIGAM prescribing information (ADMA Biologics) · U.S. National Library of Medicine, DailyMed
Need Bivigam 10 g/100 mL injection for your hospital or patient?
Send one request with the destination country and quantity. We confirm availability, lead time and the documents your regulator needs.