Livmarli (maralixibat) is an ileal bile acid transporter inhibitor for cholestatic liver disease in Alagille syndrome and progressive familial intrahepatic cholestasis, given by mouth as a weight-based oral solution or as tablets, and it is not a cold-chain product.
M Care Exports supplies Livmarli (maralixibat), marketed by Mirum, to hospital pharmacies, paediatric liver units, importers and tender desks in the GCC, Africa and the UK. If you are looking for the 9.5 mg/mL or 19 mg/mL oral solution or the 10, 15, 20 and 30 mg tablets, send the destination, the presentation and the quantity, and we quote per destination.
Maralixibat exporter and bulk supplier from India.
"We need a partner for Livmarli" 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 presentations and indications your destination registers. Livmarli is a small-volume, weight-banded rare-disease line, and it is not one product. The oral solution comes in two strengths, and the US label ties each to a condition: it says to use 9.5 mg/mL for Alagille syndrome and 19 mg/mL for progressive familial intrahepatic cholestasis (PFIC), and says the two strengths should not be substituted for one another in PFIC. The EU dosing tables give both strengths for both conditions. Tablets in four strengths are a separate line for heavier or older patients. The quote therefore turns on the strength mix, the number of 30 mL bottles or 30-tablet bottles, the registration or import route in the destination and Incoterms. Neither regulator label asks for refrigeration, so the lane is an ambient one.
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, sourced and documented for export.
Livmarli is an ileal bile acid transporter (IBAT) inhibitor whose active substance is maralixibat chloride. The US label (Mirum Pharmaceuticals Inc., DailyMed, current version published 28 April 2025) lists oral solution at 9.5 mg/mL and 19 mg/mL, and tablets of 10, 15, 20 and 30 mg. It is indicated for cholestatic pruritus in patients 3 months and older with Alagille syndrome (ALGS) and in patients 12 months and older with PFIC, with a limitation of use for a PFIC type 2 subgroup with non-functional or absent bile salt export pump protein. The EU summary of product characteristics lists the same oral solution strengths and the same four tablet strengths. The EU oral solution is indicated for cholestatic pruritus in ALGS from 2 months of age and for PFIC from 3 months of age, and the EU tablets cover adults and adolescents of 12 years and older. The EMA page names Mirum Pharmaceuticals International B.V. as marketing authorisation holder, with first authorisation on 9 December 2022. The EU authorisation is under exceptional circumstances and the product carries an orphan designation.
Active ingredient
Maralixibat chloride. Ileal bile acid transporter (IBAT) inhibitor.
Forms and strengths
9.5 mg/mL oral solution, 30 mL bottle (US label: Alagille syndrome); 19 mg/mL oral solution, 30 mL bottle (US label: PFIC); 10 mg tablet, bottle of 30; 15 mg tablet, bottle of 30; 20 mg tablet, bottle of 30; 30 mg tablet, bottle of 30.
Indications
Livmarli (maralixibat) is an ileal bile acid transporter inhibitor for Alagille syndrome and progressive familial intrahepatic cholestasis, with indications as each regulator label states. Supplied as oral solution and tablets, quoted per destination.
Administration
Oral. Oral solution; tablets.
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 hospital pharmacists in paediatric hepatology and gastroenterology units, MoH and hospital tender desks, and licensed importers and distributors in the GCC, Africa and the UK. Typical enquiries read "I'm looking for Livmarli oral solution for a paediatric liver unit" or "We need a partner for maralixibat for a ministry tender". Livmarli treats rare cholestatic liver diseases, so whether it is registered in a given destination has to be checked market by market. The buyer's route is either a registered product or an unlicensed or named-patient import, and which one applies depends on the destination regulator. Examples are the Emirates Drug Establishment (EDE) in the UAE, NAFDAC in Nigeria and the MHRA in the UK. M Care Exports confirms the route per enquiry before it quotes.
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 maralixibat.
Check the presentation against the patient before you order. The US label says to use the 9.5 mg/mL solution for ALGS and the 19 mg/mL solution for PFIC, and not to swap the two strengths in PFIC. The EU summary of product characteristics gives dosing tables for both strengths in both conditions, and asks for special attention to accurate dose calculation, given the different strengths, syringe sizes and dosing recommendations, to minimise the risk of dosing errors and overdose. Both labels give propylene glycol at 364.5 mg/mL in the solution. The US label flags a propylene glycol toxicity risk in children under 5 years, and the EU label caps the 9.5 mg/mL PFIC dose for that group and says the 9.5 mg/mL solution should not be used in PFIC with severe hepatic or renal impairment. Dosing is by weight: ALGS targets 380 mcg/kg once daily after a 190 mcg/kg start, and PFIC is titrated up to 570 mcg/kg twice daily in the US label. The US label says to take doses 30 minutes before a meal and to keep at least 4 hours between Livmarli and bile acid binding resins. An opened solution bottle is discarded after 100 days (US) or 130 days (EU).
The documentation pack a regulator actually asks for.
Livmarli is not a cold-chain product. The US label says to store the unopened product at 20 to 25 °C and to discard the oral solution 100 days after opening. The EU summary of product characteristics states no special temperature storage condition for the solution or the tablets, asks for storage in the original package to protect from light, and sets 130 days after first opening below 30 °C for the solution. EU shelf life is 30 months for the 9.5 mg/mL solution, 3 years for the 19 mg/mL solution and 2 years for the tablets. The EU authorisation is under exceptional circumstances and the product is under additional monitoring. We state the source and status of each line before quoting. M Care documentation covers batch certificates of analysis, export documents and destination-aligned dossier support where the regulator asks for it. We make no claim that M Care holds any manufacturing certification, because it is a merchant-exporter and the manufacturer holds those.
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 maralixibat.
Odevixibat
IBAT inhibitor · pruritus in PFIC and Alagille syndrome
Nitisinone
HPPD inhibitor · hereditary tyrosinaemia type 1, alkaptonuria (EU) · 2-8°C
Rifaximin
Non-absorbed rifamycin antibiotic · hepatic encephalopathy, travellers’ diarrhoea
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 maralixibat.
- 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.
Maralixibat supply, the specific questions.
What is Livmarli indicated for?
The US label lists two indications: cholestatic pruritus in patients 3 months of age and older with Alagille syndrome, and cholestatic pruritus in patients 12 months of age and older with progressive familial intrahepatic cholestasis (PFIC). It carries a limitation of use for a PFIC type 2 subgroup with non-functional or absent bile salt export pump protein. The EU oral solution is indicated for cholestatic pruritus in ALGS from 2 months of age and for PFIC from 3 months of age, and the EU tablets cover adults and adolescents of 12 years and older. Indications differ by regulator, so M Care Exports confirms the labelled use in your destination before it quotes.
How is Livmarli dosed?
Dosing is by body weight. The US label gives Alagille syndrome as 190 mcg/kg once daily for a week, then 380 mcg/kg once daily, taken 30 minutes before a meal in the morning. For PFIC it starts at 285 mcg/kg once daily and titrates to 570 mcg/kg twice daily as tolerated. The US label says tablets can be used in patients of 25 kg and above who can swallow them, while the EU label recommends the oral solution during titration and does not recommend tablets below 12 years of age. Prescribers set the dose, and the pack list follows the weight bands in the label.
What does the EMA say about Livmarli?
The EMA page lists Livmarli (maralixibat chloride) with Mirum Pharmaceuticals International B.V. as marketing authorisation holder and a marketing authorisation issued on 9 December 2022. The authorisation is under exceptional circumstances because complete information could not be obtained, given how rare the diseases are, and the medicine has an orphan designation. The summary of product characteristics covers two oral solution strengths and four tablet strengths, and the medicine is under additional monitoring. Whether your destination follows the EU decision depends on its own regulator.
Where can I find the Livmarli prescribing information?
The US prescribing information is on DailyMed under Mirum Pharmaceuticals Inc., where the current version was published on 28 April 2025. The EU summary of product characteristics sits on the EMA page for Livmarli. M Care Exports supplies the destination-aligned product information pack with a quote, and we confirm which text your regulator expects, because the US and EU labels differ on ages, tablet use and storage.
What is the cost of Livmarli for an importer?
We do not publish a figure, because the landed price is set by several things. These are the presentation (oral solution or tablets), the strength, the pack count, the quantity, the registration or import route in the destination, and Incoterms. Livmarli is an originator rare-disease product and neither the US nor the EU label asks for refrigeration, so it ships in an ambient lane. M Care Exports quotes per destination once you send the specification.
How does Livmarli compare with Bylvay?
Both are ileal bile acid transporter (IBAT) inhibitors for cholestatic liver disease, and we supply both. On label facts, Livmarli is an oral solution or tablet from Mirum, with once-daily dosing in Alagille syndrome and a twice-daily target dose in PFIC in the US label. Bylvay (odevixibat) is a separate molecule given once daily as capsules, which the EMA overview says can be swallowed whole or opened and sprinkled on food, and its page is at odevixibat. Indications, ages and presentations differ by regulator. We do not recommend one product over the other; the prescriber and the destination registration decide.
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.
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.