Medicine
Symdeko kit
Symdeko kit is a prescription medicine containing Ivacaftor and Tezacaftor, 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 68°F to 77°F (20°C to 25°C), excursions permitted to 59°F to 86°F…
Key facts
- Active ingredient (INN)
- Ivacaftor and Tezacaftor
- Brand
- Symdeko
- Dosage form
- Kit
- Packs
- 1 kit
- Marketing authorisation holder
- Vertex Pharmaceuticals
- Manufacturer
- Vertex Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store at 68°F to 77°F (20°C to 25°C), excursions permitted to 59°F to 86°F (15°C to 30°C).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- R07AX31 Ivacaftor and Tezacaftor
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 12 February 2018
- Identifiers
- RxCUI 1243046, 1999387, 1999388 +5DailyMed set ID 302ae804-37db-44fd-ac2f-3dbdeda9aa4bNDC 51167-661, 51167-113Application NDA210491
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 * 7 tablet, film coated in 1 blister pack * 7 tablet, film coated in 1 blister pack | 51167-113-01 | Vertex Pharmaceuticals | 21 June 2019 |
| 1 kit in 1 carton * 7 tablet, film coated in 1 blister pack * 7 tablet, film coated in 1 blister pack | 51167-661-01 | Vertex Pharmaceuticals | 12 February 2018 |
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
Clinical summary
Ivacaftor and Tezacaftor is a fixed-dose combination medicine indicated for the treatment of cystic fibrosis (CF) in patients aged 6 years and older, among other approved uses. It is available as kits. MedsAcross supplies Ivacaftor and Tezacaftor 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 Ivacaftor and TezacaftorFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- SYMDEKO prescribing information (Vertex Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
- Symkevi: European public assessment report (EPAR) · European Medicines Agency
Need Symdeko 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.