Bylvay (odevixibat) is an ileal bile acid transporter inhibitor for progressive familial intrahepatic cholestasis and cholestatic pruritus in Alagille syndrome, given orally once daily by body weight as capsules or pellets and stored at room temperature.
M Care Exports supplies Bylvay (odevixibat), held in the EU and UK by Ipsen Pharma, to hospital pharmacies, paediatric liver units, importers and tender desks in the GCC, Africa and the UK. If you are looking for Bylvay or Kayfanda capsules, send the destination, the strength and the quantity, and we quote per destination.
Odevixibat exporter and bulk supplier from India.
"We need a partner for Bylvay" is a typical enquiry from a paediatric hepatology unit or a ministry tender desk. M Care is a merchant-exporter: we quote the originator product against your specification and confirm which brand and indication your destination registers. The EU splits odevixibat into two brands, Bylvay for PFIC and Kayfanda for Alagille syndrome, while the UK Bylvay SmPC and the US label cover both conditions, so the line you need depends on the destination. Odevixibat is a small-volume, weight-banded rare-disease line with four strengths, so the quote turns on strength mix, pack count, quantity and the registration or import route. The UK SmPC storage condition is do not store above 25 °C, in the original package. For another rare-disease medicine, see our nitisinone (Orfadin) page.
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.
Ileal bile acid transporter (IBAT) inhibitor for PFIC and cholestatic pruritus in Alagille syndrome, sourced and documented for export.
Odevixibat is an ileal bile acid transporter (IBAT) inhibitor taken orally once daily in the morning. The US label (DailyMed, Albireo Pharma) lists pruritus in progressive familial intrahepatic cholestasis (PFIC) from 3 months of age and cholestatic pruritus in Alagille syndrome (ALGS) from 12 months of age, and does not recommend it in a PFIC type 2 subgroup with specific ABCB11 variants. The EMA lists Bylvay (Ipsen Pharma) for PFIC from 6 months, authorised on 16 July 2021 under exceptional circumstances, and Kayfanda (Ipsen Pharma) for cholestatic pruritus in ALGS from 6 months, first authorised on 19 September 2024. The UK emc SmPC for Bylvay lists both PFIC and ALGS from 6 months. Strengths are 200, 400, 600 and 1,200 micrograms. The US label gives pellets (200 and 600 micrograms) for patients under 19.5 kg and capsules (400 and 1,200 micrograms) for 19.5 kg and above. The UK SmPC describes hard capsules in bottles of 30.
Active ingredient
Odevixibat. Ileal bile acid transporter (IBAT) inhibitor for PFIC and cholestatic pruritus in Alagille syndrome.
Forms and strengths
200 micrograms hard capsule (EU and UK) or oral pellets (US label); 400 micrograms hard capsule; 600 micrograms hard capsule (EU and UK) or oral pellets (US label); 1200 micrograms hard capsule.
Indications
Odevixibat (Bylvay, Kayfanda) is an oral IBAT inhibitor for progressive familial intrahepatic cholestasis and cholestatic pruritus in Alagille syndrome, held in the EU and UK by Ipsen Pharma, as set out in the US, EU and UK labelling.
Administration
Oral. Hard capsule (EU and UK); capsule and oral pellets (US).
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 are paediatric hepatologists and hospital pharmacists, MoH and hospital tender desks, and licensed importers and distributors in the GCC, Africa and the UK. Typical enquiries read "I'm looking for Bylvay 600 microgram capsules for a paediatric liver unit" or "We need a partner for odevixibat for a named-patient programme". For a rare-disease product, the route depends on the destination regulator: some buyers need a registered product, others an import for named patients. M Care Exports confirms the route per enquiry, for example with the Emirates Drug Establishment (EDE) in the UAE, NAFDAC in Nigeria or the MHRA in the UK, before quoting. Volumes are small and tied to a handful of patients, so orders are usually planned against weight bands and the next dose step.
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 odevixibat.
Dosing is by body weight, so the pack plan is a weight-band plan. For PFIC the US label and the UK SmPC start at 40 micrograms/kg once daily in the morning. If there is no improvement after 3 months, the dose can be raised to 120 micrograms/kg/day. The US label caps PFIC dosing at 6 mg/day. In the UK SmPC weight table, 120 micrograms/kg/day comes to 7,200 micrograms a day at 55.5 kg and above, and the US Alagille table gives the same 7,200 micrograms. For Alagille syndrome the US label and the UK SmPC give 120 micrograms/kg once daily in the morning. Check three label points before a first order: baseline liver tests, with frequent monitoring in the first months on the US label; diarrhoea and dehydration, with interruption on the US label if diarrhoea persists; and baseline and ongoing fat-soluble vitamin and INR checks, with supplementation where indicated. The US label also contraindicates use after prior or active hepatic decompensation events such as variceal haemorrhage, ascites or hepatic encephalopathy. For children who cannot swallow capsules, the UK SmPC allows them to be opened and sprinkled on soft food or in a liquid. Storage on the UK SmPC is not above 25 °C in the original package, protected from light.
The documentation pack a regulator actually asks for.
Odevixibat is a room-temperature product. The UK emc SmPC says keep in the original package to protect from light and do not store above 25 °C, with a 4-year shelf life and a 30-capsule HDPE bottle with a child-resistant closure. The US label gives 20 to 25 °C with excursions to 15 to 30 °C. The EMA names Ipsen Pharma, Paris, as marketing authorisation holder for Bylvay and Kayfanda, and the UK SmPC lists Ipsen Pharma as holder of marketing authorisation PLGB 28247/0011. Bylvay carries EU orphan designation for PFIC, and the EMA says it was authorised under exceptional circumstances because the condition is so rare that complete information could not be obtained. M Care documentation covers batch certificates of analysis, export documents and destination-aligned dossier support where the regulator requires it. M Care makes no manufacturing or quality-status claim for itself beyond merchant-exporter documentation.
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 odevixibat.
Asfotase alfa
Enzyme replacement therapy · paediatric-onset hypophosphatasia · 2-8°C
Icatibant
Bradykinin B2 receptor antagonist · acute attacks of hereditary angioedema
Rifaximin
Non-absorbable rifamycin antibiotic · traveller's diarrhoea, hepatic encephalopathy
Maralixibat (Livmarli)
IBAT inhibitor · cholestatic pruritus in Alagille syndrome and PFIC
All gastroenterology
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 odevixibat.
- 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.
Odevixibat supply, the specific questions.
What is the price or cost of Bylvay for an importer?
We do not publish prices. The landed cost of Bylvay depends on whether you need Bylvay or the EU Alagille brand Kayfanda, the strengths and the number of bottles of 30, the quantity, the registration or named-patient route in your destination and Incoterms. The UK SmPC storage condition is not above 25 °C, which shapes the freight plan. M Care Exports quotes per destination once you send the strengths, volume and country.
What is the Bylvay indication, and what is the difference between Bylvay and Kayfanda?
The US label lists pruritus in PFIC from 3 months of age and cholestatic pruritus in Alagille syndrome from 12 months. In the EU the EMA lists Bylvay for PFIC from 6 months and Kayfanda for cholestatic pruritus in Alagille syndrome from 6 months, both held by Ipsen Pharma. The UK emc SmPC for Bylvay lists PFIC and Alagille syndrome from 6 months. Check the SmPC or EPAR for your destination, because the brand and indication that a regulator accepts differ by market.
What is the Bylvay dose, and how is it given?
Odevixibat is given orally once daily in the morning, by body weight. For PFIC the US label and UK SmPC start at 40 micrograms/kg and allow a rise to 120 micrograms/kg/day if there is no improvement after 3 months. For Alagille syndrome the dose is 120 micrograms/kg/day. Strengths are 200, 400, 600 and 1,200 micrograms, and the US label uses pellets of 200 and 600 micrograms for patients under 19.5 kg. Confirm the exact dose and presentation against the label for your market.
How does odevixibat compare with maralixibat (Livmarli)?
We compare on label facts only and do not recommend one over the other. Both block the ileal bile acid transporter (IBAT). Bylvay (odevixibat) comes as capsules, or capsules and oral pellets in the US, dosed once daily in the morning by weight. Livmarli (maralixibat, Mirum Pharmaceuticals International B.V.) is listed by the EMA as an oral solution and tablets, for cholestatic pruritus in Alagille syndrome from 2 months and PFIC from 3 months, with tablets for ages 12 and over. Presentation, age limits and indications differ by regulator, so confirm both labels for your market.
Is Bylvay used for biliary atresia?
No. Biliary atresia is not a labelled indication for Bylvay in the US, EU or UK texts we read, which list PFIC and Alagille syndrome. M Care Exports does not promote any use outside the labelled indications. A prescriber decides on treatment in any individual patient.
Is there an odevixibat tablet or a generic odevixibat?
There is no tablet in the labels we read. Odevixibat comes as hard capsules in the EU and UK, and as capsules and oral pellets in the US. The UK SmPC allows the capsules to be opened and sprinkled on soft food or in a liquid for children who cannot swallow them. We found no generic odevixibat on the US label, the EMA pages or the UK emc listing, which show the originator brands. If you are looking for odevixibat, M Care Exports confirms the brand and strengths available for your destination.
Who stands behind this page, and where its statements come from.
Reviewed by Dr. Rajat Bhatt, PharmD, Managing Director, M Care Exports. Last reviewed 2026-11-08.
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.
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