Medicine
Kalydeco 150 mg tablet
Kalydeco 150 mg tablet is a prescription medicine containing Ivacaftor for oral use, 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°C-25°C (68°F-77°F), excursions permitted to 15°C-30°C (59°F-86°F).
Key facts
- Active ingredient (INN)
- Ivacaftor
- Brand
- Kalydeco
- Strength
- 150 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 4 blister pack, 1 bottle
- Marketing authorisation holder
- Vertex Pharmaceuticals
- Manufacturer
- Vertex Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store at 20°C-25°C (68°F-77°F), excursions permitted to 15°C-30°C (59°F-86°F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- R07AX02 Ivacaftor
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 31 January 2012
- Identifiers
- RxCUI 1243046, 1243052, 1606862 +7DailyMed set ID 0ab0c9f8-3eee-4e0f-9f3f-c1e16aaffe25NDC 51167-200Application NDA203188
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 / 14 tablet, film coated in 1 blister pack | 51167-200-01 | Vertex Pharmaceuticals | 31 January 2012 |
| 1 bottle in 1 carton / 60 tablet, film coated in 1 bottle | 51167-200-02 | Vertex Pharmaceuticals | 31 January 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 Ivacaftor
Clinical summary
Ivacaftor is a cystic fibrosis transmembrane conductance regulator potentiator indicated for the treatment of cystic fibrosis (CF) in patients aged 1 month and older, among other approved uses. MedsAcross supplies 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 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
- Kalydeco prescribing information (Vertex Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
- Kalydeco: European public assessment report (EPAR) · European Medicines Agency
Need Kalydeco 150 mg tablet 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.