Trikafta (Kaftrio in the EU): triple CFTR modulator for cystic fibrosis, from age 2
M Care Exports supplies Trikafta, marketed as Kaftrio in the European Union, the elexacaftor/tezacaftor/ivacaftor combination from Vertex for cystic fibrosis. Enquiries often begin with "I'm looking for Trikafta", and the answer depends on strength, tablet or granule form and the destination's registration route. M Care is a merchant-exporter: we source and dispatch on quote and do not manufacture.
Elexacaftor/tezacaftor/ivacaftor exporter and bulk supplier from India.
"We need a partner for Trikafta" is how many importer and hospital enquiries start, and the specification has more variables than a typical tablet. Trikafta is a co-packaged regimen of morning elexacaftor/tezacaftor/ivacaftor tablets plus an evening ivacaftor tablet, in two tablet strengths for ages 6 and over and two granule strengths for ages 2 to under 6. M Care Exports quotes against the strength, the form, the carton count, the quantity and the destination's registration route. Licensed importers, hospital pharmacies running CF clinics and ministry tender desks tell us the age band of their patients first, because that decides which of the four presentations they need.
Source
WHO-GMP-certified Indian manufacturing line, named on every quote.
Minimum order
No blanket MOQ. Set by the source manufacturer's minimum batch-release quantity for the strength and pack ordered.
Pricing
On request. Indicative FOB or CIF quote, formal proforma on confirmation.
Incoterms
EXW, FOB, CIF, CIP or DAP.
Payment
Letter of credit (sight or usance) and telegraphic transfer.
Documentation
WHO-GMP certificate of the source line, product-specific CoPP, batch CoA, method of analysis, Free Sale Certificate, Certificate of Origin, CTD or eCTD dossier. On request.
Shelf-life
Minimum remaining shelf-life agreed per order and confirmed on the proforma.
Response
Availability and CoPP status within two working days; pre-alert documents before dispatch.
CFTR modulator (cystic fibrosis transmembrane conductance regulator potentiator and correctors), sourced and documented for export.
Trikafta (elexacaftor, tezacaftor and ivacaftor) is a CFTR modulator regimen for cystic fibrosis. The US label covers patients aged 2 years and older with at least one CFTR variant that is responsive to the combination, and says an FDA-cleared genetic test should confirm the variant if the genotype is unknown. The EU product Kaftrio is authorised for use with ivacaftor in people with at least one non-Class I CFTR mutation: tablets from age 6, granules for ages 2 to under 6. The EU marketing authorisation was issued on 21 August 2020, and the EMA lists an orphan designation from 14 December 2018. The US label carries a boxed warning for drug-induced liver injury and liver failure. Tablets and granules are stored at 20 to 25 degrees C with excursions permitted between 15 and 30 degrees C, so Trikafta does not need a cold chain. Each four-wallet tablet carton holds 84 tablets and each granule carton holds 56 packets, per the DailyMed label.
Active ingredient
Elexacaftor, tezacaftor and ivacaftor (with separate ivacaftor evening dose). CFTR modulator (cystic fibrosis transmembrane conductance regulator potentiator and correctors).
Forms and strengths
50/25/37.5 mg elexacaftor/tezacaftor/ivacaftor tablet, co-packaged with ivacaftor 75 mg tablet; 100/50/75 mg elexacaftor/tezacaftor/ivacaftor tablet, co-packaged with ivacaftor 150 mg tablet; 80/40/60 mg elexacaftor/tezacaftor/ivacaftor granules, co-packaged with ivacaftor 59.5 mg granules; 100/50/75 mg elexacaftor/tezacaftor/ivacaftor granules, co-packaged with ivacaftor 75 mg granules.
Indications
Elexacaftor/tezacaftor/ivacaftor co-packaged with ivacaftor is a CFTR modulator regimen for cystic fibrosis in patients with a responsive CFTR variant. Marketed as Trikafta in the US and Kaftrio in the EU by Vertex.
Administration
Oral. Co-packaged film-coated tablets and oral granules.
Documentation
Batch-specific CoA, CoPP, manufacturing-site WHO-GMP certificate and stability data compiled per consignment, in the format the destination regulator expects.
Hospital pharmacies, licensed importers and tender desks across our export markets.
India is our origin. We do not sell into the Indian market.
Buyers for Trikafta are specialist cystic fibrosis centres and their hospital pharmacies, ministry of health and hospital tender desks running rare-disease or specialised-medicines lists, licensed importers and distributors that hold the destination registration or named-patient route, and NGO or foundation programmes supporting CF access. Prescribing is specialist-led, genotype-confirmed and monitored by liver function testing, so orders are small, repeating and driven by a named patient list. We see enquiries from the GCC, Africa and the UK, where the question is usually continuity of supply for an existing patient cohort or a first registration path for a new market.
GCC registration routes
Supply against MoH registration held by your local licensed importer, or via the GCC central registration pathway.
UK unlicensed routes
Where no UK licence exists, the MHRA Specials and named-patient import routes cover clinically justified demand.
Tender desks
Bid-pack documentation assembled to the tender's specification, from CoPP to batch records.
Dossier support
CTD documentation from the sourcing manufacturer, compiled for your regulator's format.
What the dispensing pharmacist checks on elexacaftor/tezacaftor/ivacaftor.
Treat Trikafta as a regimen, not a single tablet. For ages 12 and over the label dose is two elexacaftor 100 mg/tezacaftor 50 mg/ivacaftor 75 mg tablets in the morning and one ivacaftor 150 mg tablet about 12 hours later, both with fat-containing food. Children 6 to under 12 take the lower-strength tablets if under 30 kg and the adult-strength tablets if 30 kg or over. Ages 2 to under 6 use granule packets mixed in 5 mL of soft food or liquid and taken within one hour, with the strength set by a 14 kg weight cut-off. The boxed warning requires liver function tests before starting, monthly for six months, every three months for the next twelve, then at least annually. It is not recommended in moderate hepatic impairment (Child-Pugh B) and must not be used in Child-Pugh C. Strong CYP3A inhibitors such as itraconazole, posaconazole and clarithromycin, and moderate inhibitors such as fluconazole, change the schedule, and grapefruit is to be avoided. Storage is ambient, so the procurement risk is supply continuity and patient-level dose planning, not temperature excursions.
The documentation pack a regulator actually asks for.
Trikafta is a Vertex originator product. The US label is held by Vertex Pharmaceuticals Incorporated, and the EU authorisation for Kaftrio is held by Vertex Pharmaceuticals (Ireland) Limited. The DailyMed label record we reviewed lists the brand only. For importers the practical consequence is that the destination registration route comes first: ask the national regulator (for the UAE, the Emirates Drug Establishment, EDE) whether the product is registered, or whether a named-patient or special-import route applies. We confirm batch documentation, shelf life on arrival and carton and wallet integrity before dispatch. We did not find a regulator page confirming Trikafta registration status for the UAE, Saudi Arabia or Nigeria, so we do not assert one. M Care is a merchant-exporter and holds no manufacturing authorisation for this product.
CoA and MoA, per batch
Batch-specific certificate and method of analysis from the sourcing manufacturer's QC release.
CoPP, WHO-GMP, MFG licence
Certificate of pharmaceutical product and site GMP certification issued via CDSCO channels, naming the actual manufacturing site.
CTD Module 3
Chemistry, manufacturing and controls documentation available from the sourcing manufacturer for registration filings.
Pack insert, labels, artwork
Destination-language patient information and labelling to the local regulator's standard, locked before shipment.
Pharmacovigilance
A named PV contact arranged in the destination market where the registration requires one.
Adjacent lines procurement desks order alongside elexacaftor/tezacaftor/ivacaftor.
Colistimethate sodium
Polymyxin antibiotic, including the inhaled use in cystic fibrosis care
Azithromycin
Macrolide antibiotic ordered by the same respiratory and paediatric services
Salbutamol
SABA · acute bronchospasm, asthma reliever, acute COPD exacerbation · NICE NG80 / NG115 · WHO EML core
All respiratory
The full category listing for procurement desks.
Molecule · strength · volume · destination. One working day to a quote.
- Send us the specifics. Form and strength, pack preference, destination market and indicative volume for elexacaftor/tezacaftor/ivacaftor.
- We route to the right line. The enquiry goes to the WHO-GMP certified manufacturing partner whose certificates fit your regulator.
- Commercial and regulatory offer. FOB or CIF price with the documentation list, named manufacturing site and current certificate validity.
- Order, produce, release, ship. QC release on the Indian side, batch documents compiled, despatch on the agreed incoterm.
- After delivery. Batch records and certificates archived and retrievable for the life of the product on your shelf.
Elexacaftor/tezacaftor/ivacaftor supply, the specific questions.
I'm looking for the Trikafta price. What sets it for an importer?
We do not publish a figure, because the landed price for Trikafta depends on variables that change per order. These are originator or any alternative source, the tablet or granule presentation and strength, carton count and quantity, the destination's registration or named-patient route, import duties and Incoterms, and freight. Tablets and granules store at ambient temperature, so cold-chain cost is not a driver. M Care Exports quotes per destination once we know the age band of the patients and the quantity. The same logic applies if you are asking about Trikafta cost.
Is there a generic Trikafta?
The US DailyMed record lists Trikafta under Vertex, and the EMA lists Kaftrio under a single marketing authorisation holder, Vertex Pharmaceuticals (Ireland) Limited. We found no US or EU generic in the sources we fetched. Whether any version can be imported depends on the destination's registration and patent position, which we check with you before quoting.
Who is the Trikafta manufacturer, and what is Kaftrio?
Trikafta is a Vertex product. The US label lists Vertex Pharmaceuticals Incorporated, and the EU authorisation for Kaftrio is held by Vertex Pharmaceuticals (Ireland) Limited. Kaftrio is the EU name for the same three active substances, used with ivacaftor, authorised on 21 August 2020. M Care Exports is not the manufacturer: we are a merchant-exporter and source against your specification.
We need a partner for Trikafta tablets and granules. What forms exist?
The US label lists four co-packaged presentations. Tablets are elexacaftor 50 mg/tezacaftor 25 mg/ivacaftor 37.5 mg with ivacaftor 75 mg, and elexacaftor 100 mg/tezacaftor 50 mg/ivacaftor 75 mg with ivacaftor 150 mg. Granule packets are elexacaftor 80 mg/tezacaftor 40 mg/ivacaftor 60 mg with ivacaftor 59.5 mg, and elexacaftor 100 mg/tezacaftor 50 mg/ivacaftor 75 mg with ivacaftor 75 mg. Tablet cartons hold 84 tablets in four wallets and granule cartons hold 56 packets. Tell us the patient age and weight bands and we match the presentation.
Trikafta vs Alyftrek: which should we list?
Alyftrek (vanzacaftor/tezacaftor/deutivacaftor) is a separate, newer Vertex CFTR modulator. The EMA page shows it authorised in the EU on 30 June 2025 for people aged 6 and over with at least one non-Class I CFTR mutation, as once-daily tablets taken with fat-containing food. Trikafta is taken morning and evening. Which one a ministry or hospital lists depends on its registration, age coverage and formulary. Kaftrio and Trikafta are the established products. We can quote either brand on request.
What are the side effects and cystic fibrosis scope of Trikafta?
Trikafta treats cystic fibrosis in patients with a responsive CFTR variant, from age 2 in the US. The EMA overview lists headache, diarrhoea and upper respiratory tract infection as the most common side effects, and notes rashes may occur. The US boxed warning concerns drug-induced liver injury and liver failure, with liver function monitoring required. Prescribing is specialist-only. Importers should keep the current local prescribing information with each shipment, because a pharmacist or clinic will rely on the destination's approved text rather than ours.
Who stands behind this page, and where its statements come from.
Reviewed by Dr. Rajat Bhatt, PharmD, Managing Director, M Care Exports. Last reviewed 2026-11-07.
This page is sourcing information for licensed importers, hospital procurement and tender desks. It is not medical, pharmaceutical or prescribing advice, and it is not a substitute for the approved product information of the line on your order. See our full disclaimer.
Send the specifics. You'll have a price inside one working day.
Form and strength, destination market and indicative volume. The Mumbai desk replies within one working day, including when the honest answer is that the route is not viable yet.