Medicine
Tretten kit
Tretten kit is a prescription medicine containing Coagulation factor xiii a-subunit, marketed by Novo Nordisk, 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 refrigerated at 2°C – 8°C (36°F – 46°F) prior to reconstitution. Store…
Key facts
- Active ingredient (INN)
- Coagulation factor xiii a-subunit
- Brand
- Tretten
- Dosage form
- Kit
- Packs
- 1 kit
- Marketing authorisation holder
- Novo Nordisk
- Manufacturer
- Novo Nordisk
- Origin register
- US FDA, United States
- Storage
- Store refrigerated at 2°C – 8°C (36°F – 46°F) prior to reconstitution. Store protected from light. • Use reconstituted TRETTEN within 3 hours. • If the reconstituted product is not used immediately, store the solution refrigerated or at room temperature not to exceed 25°C (77°F) for up to 3 hours following reconstitution.
- Cold chain
- Yes, shipped temperature controlled
- 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
- 23 December 2013
- Identifiers
- RxCUI 1488302, 1488304DailyMed set ID 8664978e-1814-4930-aca5-97a24455f6dfNDC 0169-7013Application BLA125398
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 kit * 3 mL in 1 vial, glass * 3.2 mL in 1 vial, glass | 0169-7013-01 | Novo Nordisk | 23 December 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
Clinical summary
Coagulation factor xiii a-subunit is a prescription medicine indicated for routine prophylaxis for bleeding in patients with congenital factor XIII A-subunit deficiency. It is available as kits. MedsAcross supplies Coagulation factor xiii a-subunit 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 Coagulation factor xiii a-subunitFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- TRETTEN prescribing information (Novo Nordisk) · U.S. National Library of Medicine, DailyMed
Need Tretten 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.