Medicine
Gammaplex 20 g/200 mL injection
Gammaplex 20 g/200 mL injection is a prescription medicine containing Human immunoglobulin g for intravenous use, marketed by Bio Products Laboratory, 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.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Ambient
Do not freeze. When stored between 2°C [35.6°F] and 25°C [77°F]), GAMMAPLEX…
Key facts
- Active ingredient (INN)
- Human immunoglobulin g
- Brand
- Gammaplex
- Strength
- 20 g/200 mL
- Dosage form
- Injection
- Route
- Intravenous
- Packs
- 1 bottle of 200 mL
- Marketing authorisation holder
- Bio Products Laboratory
- Manufacturer
- Bio Products Laboratory
- Origin register
- US FDA, United States
- Storage
- Do not freeze. When stored between 2°C [35.6°F] and 25°C [77°F]), GAMMAPLEX 10% has a shelf life of 36 months. Do not shake.
- Cold chain
- Not required on record
- 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
- 7 April 2017
- Identifiers
- RxCUI 1809414, 1809421, 1809444 +3DailyMed set ID 2098af41-aec7-4af7-98bb-54f8ab55f30eNDC 64208-8235Application BLA125329
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 bottle, glass in 1 carton / 200 mL in 1 bottle, glass | 64208-8235-7 | Bio Products Laboratory | 7 April 2017 |
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 20 g/200 mL injection.
- Yimmugo 20 g/200 mL injectionAvailable on requestBiotestUS FDA2 packs Cold chain
- Gammaked 20 g/200 mL injectionAvailable on requestKedrion BiopharmaUS FDA1 pack
- Gamunex-C 20 g/200 mL injectionAvailable on requestGrifolsUS FDA1 pack
- Gamunex-C 20 g/200 mL injectionAvailable on requestGrifolsUS FDA1 pack
- Privigen 20 g/200 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 Gammaplex 20 g/200 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.