Medicine
Trikafta kit
Trikafta kit is a prescription medicine containing Elexacaftor and Ivacaftor, marketed by Vertex 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
Store at 20 ºC – 25 ºC (68 ºF – 77 ºF), excursions permitted to 15 ºC – 30 ºC…
Key facts
- Active ingredient (INN)
- Elexacaftor and Ivacaftor
- Brand
- Trikafta
- Dosage form
- Kit
- Packs
- 4 blister pack
- Marketing authorisation holder
- Vertex Pharmaceuticals
- Manufacturer
- Vertex Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store at 20 ºC – 25 ºC (68 ºF – 77 ºF), excursions permitted to 15 ºC – 30 ºC (59 ºF – 86 ºF).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 21 October 2019
- Identifiers
- RxCUI 1243046, 1606868, 2174388 +7DailyMed set ID f354423a-85c2-41c3-a9db-0f3aee135d8dNDC 51167-106, 51167-331Application NDA212273
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 |
|---|---|---|---|
| 4 blister pack in 1 carton / 1 kit in 1 blister pack * 14 tablet, film coated in 1 blister pack * 7 tablet, film coated in 1 blister pack | 51167-106-02 | Vertex Pharmaceuticals | 8 June 2021 |
| 4 blister pack in 1 carton / 1 kit in 1 blister pack * 14 tablet, film coated in 1 blister pack * 7 tablet, film coated in 1 blister pack | 51167-331-01 | Vertex Pharmaceuticals | 21 October 2019 |
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 Elexacaftor and Ivacaftor kit.
Clinical summary
Elexacaftor and Ivacaftor is a fixed-dose combination medicine indicated for the treatment of cystic fibrosis (CF) in adult and pediatric patients aged 2 years and older, among other approved uses. It is available as kits. MedsAcross supplies Elexacaftor and Ivacaftor 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 Elexacaftor and IvacaftorFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Trikafta prescribing information (Vertex Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
Need Trikafta 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.