Medicine
Gattex kit
Gattex kit is a prescription medicine containing Teduglutide, 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. 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 GATTEX 5 mg Strength one-vial kits refrigerated at 2°C to 8°C (36°F to…
Key facts
- Active ingredient (INN)
- Teduglutide
- Brand
- Gattex
- Dosage form
- Kit
- Packs
- 1 kit
- Marketing authorisation holder
- Takeda Pharmaceuticals
- Manufacturer
- Takeda Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store GATTEX 5 mg Strength one-vial kits refrigerated at 2°C to 8°C (36°F to 46°F). Do not freeze. Do not freeze. Do not freeze. After Dispensing by the Pharmacist: Store GATTEX 5 mg Strength one-vial kits at room temperature up to 25°C (77°F). Store the Carton of Ancillary Supplies at room temperature up to 25°C (77°F).
- Cold chain
- Yes, shipped temperature controlled
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- A16AX08 Teduglutide
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 21 December 2012
- Identifiers
- RxCUI 1364472, 1364477, 1489307DailyMed set ID 66b69c1e-b25c-44d3-b5ff-1c1de9a516faNDC 68875-0102, 68875-0103Application NDA203441
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 * .5 mL in 1 syringe, plastic * .7 mL in 1 packet * .5 mL in 1 vial | 68875-0102-1 | Takeda Pharmaceuticals | 21 December 2012 |
| 1 kit in 1 carton * .5 mL in 1 syringe, plastic * .7 mL in 1 packet * .5 mL in 1 vial | 68875-0103-1 | Takeda Pharmaceuticals | 21 December 2012 |
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.
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
Other strengths and forms of Teduglutide
Clinical summary
Teduglutide is a GLP-2 analog indicated for the treatment of adults and pediatric patients 1 year of age and older with Short Bowel Syndrome (SBS) who are dependent on parenteral support. MedsAcross supplies Teduglutide 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 TeduglutideFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Gattex prescribing information (Takeda Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
- Revestive: European public assessment report (EPAR) · European Medicines Agency
- Teduglutide Viatris: European public assessment report (EPAR) · European Medicines Agency
Need Gattex 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.