Medicine
Gammagard S/D kit
Gammagard S/D kit is a prescription medicine containing Immune globulin intravenous, marketed by Takeda Pharmaceuticals, 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. Store GAMMAGARD S/D at a temperature not to exceed 25ºC (77ºF)…
Key facts
- Active ingredient (INN)
- Immune globulin intravenous
- Brand
- Gammagard S/D
- Dosage form
- Kit
- Packs
- 1 kit
- Marketing authorisation holder
- Takeda Pharmaceuticals
- Manufacturer
- Takeda Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Do not Freeze. Store GAMMAGARD S/D at a temperature not to exceed 25ºC (77ºF) for 24 months.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- HS code (indicative)
- 3002.12Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 10 May 1994
- Identifiers
- RxCUI 1809728, 1809730, 1809736 +1DailyMed set ID bf8df9fd-bfdd-47c2-84d2-d91e50947bf6NDC 0944-2656, 0944-2658Application BLA103133
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 kit in 1 carton * 96 mL in 1 bottle * 96 mL in 1 bottle * 100 mL in 1 bottle | 0944-2656-03 | Takeda Pharmaceuticals | 10 May 1994 |
| 1 kit in 1 carton * 192 mL in 1 bottle * 192 mL in 1 bottle * 200 mL in 1 bottle | 0944-2658-04 | Takeda Pharmaceuticals | 10 May 1994 |
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
Clinical summary
Immune globulin intravenous is a prescription medicine indicated for treatment of primary immunodeficiency (PI) in adults and pediatric patients two years of age or older, among other approved uses. It is available as kits. MedsAcross supplies Immune globulin intravenous 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 Immune globulin intravenousFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- GAMMAGARD S/D prescribing information (Takeda Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
Need Gammagard S/D kit 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.