Suppliers and packagers for LIVMARLI

LIVMARLI

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Mirum	LIVMARLI	maralixibat chloride	SOLUTION;ORAL	214662	NDA	Mirum Pharmaceuticals Inc.	79378-110-01	1 BOTTLE in 1 CARTON (79378-110-01) / 30 mL in 1 BOTTLE	2021-09-29
Mirum	LIVMARLI	maralixibat chloride	SOLUTION;ORAL	214662	NDA	Mirum Pharmaceuticals Inc.	79378-111-01	1 BOTTLE in 1 CARTON (79378-111-01) / 30 mL in 1 BOTTLE	2024-07-24
Mirum	LIVMARLI	maralixibat chloride	TABLET;ORAL	219485	NDA	Mirum Pharmaceuticals Inc.	79378-210-30	1 BOTTLE in 1 CARTON (79378-210-30) / 30 TABLET in 1 BOTTLE	2025-04-10
Mirum	LIVMARLI	maralixibat chloride	TABLET;ORAL	219485	NDA	Mirum Pharmaceuticals Inc.	79378-215-30	1 BOTTLE in 1 CARTON (79378-215-30) / 30 TABLET in 1 BOTTLE	2025-04-10
Mirum	LIVMARLI	maralixibat chloride	TABLET;ORAL	219485	NDA	Mirum Pharmaceuticals Inc.	79378-220-30	1 BOTTLE in 1 CARTON (79378-220-30) / 30 TABLET in 1 BOTTLE	2025-04-10

LIVMARLI Supplier Landscape Analysis

Last updated: February 19, 2026

This report analyzes key suppliers for LIVMARLI (maralixibat oral solution), a pharmaceutical drug approved for conditions such as progressive familial intrahepatic cholestasis (PFIC) and Alagille syndrome. The analysis focuses on critical components, manufacturing, and potential supply chain vulnerabilities.

What is LIVMARLI and its Active Pharmaceutical Ingredient?

LIVMARLI is an orally administered ileal bile acid transporter (IBAT) inhibitor. Its active pharmaceutical ingredient (API) is maralixibat. Maralixibat is a novel, non-systemically absorbed, minimally metabolized investigational drug that acts locally in the small intestine. It works by inhibiting the IBAT protein, which reduces the absorption of bile acids from the intestine back into the liver. This leads to a decrease in the total bile acid pool and hepatic exposure, thereby alleviating pruritus and improving liver function in patients with cholestatic liver diseases [1].

The chemical name for maralixibat is 2-((3R,5S,6E)-6-(4-chlorophenyl)-7-oxo-5-(thiophen-2-yl)-1,4-dithia-2-azabicyclo[3.2.1]oct-2-en-3-yl)acetic acid. Its molecular formula is C16H12ClNO2S3, and its molecular weight is 385.88 g/mol [2].

Key Suppliers for Maralixibat API

The synthesis of maralixibat is a complex multi-step process requiring specialized chemical expertise and manufacturing capabilities. While specific details of commercial supply agreements are often proprietary, publicly available information and patent filings offer insights into potential suppliers.

API Manufacturing Capabilities

The synthesis of maralixibat involves stereoselective reactions and the handling of sulfur-containing heterocycles. Companies with demonstrated expertise in complex organic synthesis, chiral chemistry, and the production of pharmaceutical intermediates are likely candidates.

• General Capabilities:
  • Multi-step organic synthesis
  • Chiral synthesis and resolution
  • Heterocyclic chemistry
  • Process optimization and scale-up
  • cGMP manufacturing

Identified Potential API Suppliers

Based on patent literature and industry intelligence, several Contract Development and Manufacturing Organizations (CDMOs) possess the requisite capabilities.

• Albemarle Corporation: A global specialty chemicals company with significant API manufacturing operations. Albemarle has expertise in complex synthesis and has been involved in the production of various pharmaceutical ingredients.
• Lonza Group AG: A leading global supplier to the pharmaceutical, biotech, and nutrition markets. Lonza has extensive experience in small molecule API manufacturing, including complex chemistries and cGMP production.
• Catalent, Inc.: A global provider of differentiated delivery technologies and solutions for drugs, biologics, gene therapies, and consumer health products. Catalent offers integrated services from development to commercial manufacturing of APIs.
• WuXi AppTec Co., Ltd.: A leading global pharmaceutical, biopharmaceutical, and medical device open-access capability and technology platform company. WuXi AppTec provides a broad range of R&D and manufacturing services, including API synthesis.

Note: Direct confirmation of any company's role as a primary supplier for maralixibat API is not publicly disclosed by the drug sponsor, Mirum Pharmaceuticals.

Suppliers for LIVMARLI Formulation and Drug Product Manufacturing

Beyond the API, the formulation of LIVMARLI into an oral solution requires specialized excipients and manufacturing processes.

Excipients for Oral Solutions

Oral solutions require a specific set of excipients to ensure solubility, stability, palatability, and appropriate bioavailability. Key excipients include:

• Solvents/Co-solvents: Water for injection, propylene glycol, ethanol.
• Sweeteners: Sucrose, sorbitol, sucralose, acesulfame potassium.
• Flavoring Agents: Natural or artificial flavors to mask the taste of the API.
• Preservatives: Sodium benzoate, potassium sorbate, parabens (if applicable).
• Buffering Agents: Citric acid, sodium citrate, phosphates to maintain pH.
• Viscosity Modifiers: Hydroxypropyl methylcellulose (HPMC), xanthan gum.
• Stabilizers: Antioxidants, chelating agents.

Key Excipient Suppliers

The pharmaceutical industry relies on a global network of excipient manufacturers. Major suppliers include:

• BASF SE: A leading supplier of pharmaceutical excipients, offering a wide range of products including solvents, emollients, and polymers.
• Dow Inc.: Provides cellulose ethers, which can be used as thickeners and stabilizers in oral solutions.
• Roquette Frères: A global player in plant-based ingredients, offering polyols and other functional ingredients for pharmaceutical formulations.
• Ingredion Incorporated: Offers starches, sweeteners, and texturants that can be utilized in liquid dosage forms.
• International Flavors & Fragrances Inc. (IFF): A major supplier of flavors and functional ingredients.

Drug Product Manufacturing

The final drug product, LIVMARLI oral solution, is manufactured under strict Good Manufacturing Practice (GMP) regulations. This involves precise blending, dissolution, filtration, and packaging. Mirum Pharmaceuticals may outsource this manufacturing to a specialized CDMO or conduct it in-house.

• Potential CDMOs for Formulation and Fill-Finish:
  • Catalent, Inc.: Offers comprehensive drug product development and manufacturing services, including sterile and non-sterile liquid dosage forms.
  • Thermo Fisher Scientific Inc. (Patheon brand): A significant player in pharmaceutical contract manufacturing, with capabilities for sterile and non-sterile liquid fills.
  • AbbVie Inc. (via its contract manufacturing services): While primarily a drug developer, larger pharmaceutical companies sometimes offer contract manufacturing.

Packaging and Distribution Suppliers

The packaging of LIVMARLI oral solution is critical for maintaining product integrity and ensuring patient safety. Distribution requires specialized logistics for temperature-controlled transport.

Primary Packaging Suppliers

Primary packaging components are in direct contact with the drug product. For an oral solution, this typically includes:

• Bottles: High-density polyethylene (HDPE) or glass bottles.
• Closures: Child-resistant caps, often with tamper-evident seals.
• Dosing Devices: Oral syringes, calibrated cups, or droppers.

Key Suppliers for Primary Packaging:

• Amcor plc: A global leader in developing and producing responsible packaging for food, beverage, medical, and other industries.
• Berry Global Group, Inc.: Manufactures a wide range of plastic packaging products, including bottles and closures.
• Gerresheimer AG: A leading supplier of specialty glass and plastic products for the pharmaceutical industry, including bottles and closures.

Secondary Packaging and Labeling Suppliers

Secondary packaging protects the primary container, and labeling provides essential product information and regulatory compliance.

• Cartons and Labels: Specialized printing companies with pharmaceutical expertise.
• Track and Trace Solutions: Systems for serialization and aggregation to comply with regulations like the Drug Supply Chain Security Act (DSCSA).

Key Suppliers for Secondary Packaging and Labeling:

• Fruition Packaging: Offers custom packaging solutions for the pharmaceutical industry.
• Seismic: Provides serialization and aggregation software for pharmaceutical supply chains.

Distribution and Logistics

Specialized cold chain logistics may be required if LIVMARLI has specific temperature stability requirements, though oral solutions are often less sensitive than biologics.

Key Logistics Providers:

• Kuehne + Nagel International AG: Offers global supply chain solutions, including pharmaceutical logistics.
• DB Schenker: Provides logistics and supply chain management services worldwide.
• Prologistix: A leading provider of warehouse and distribution services.

Regulatory Considerations and Supplier Qualification

The selection and qualification of suppliers for pharmaceutical manufacturing are governed by stringent regulatory requirements, including those from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

Key Regulatory Requirements

• cGMP Compliance: All suppliers of APIs, excipients, and drug products must adhere to current Good Manufacturing Practices (cGMP) as outlined in 21 CFR Part 210 and 211 in the U.S.
• Drug Master Files (DMFs): API suppliers often submit DMFs to regulatory agencies, providing confidential detailed information about manufacturing processes, facilities, and quality controls.
• Supplier Audits: Pharmaceutical companies conduct regular audits of their suppliers to ensure ongoing compliance with quality standards and regulatory requirements.
• Quality Agreements: Formal quality agreements are established between the drug sponsor and each critical supplier to define roles, responsibilities, and quality expectations.
• Change Control: Any changes to manufacturing processes, materials, or facilities by a supplier must be communicated to and approved by the drug sponsor.

Mirum Pharmaceuticals' Role

Mirum Pharmaceuticals, as the drug sponsor, is ultimately responsible for the quality and safety of LIVMARLI. This includes:

• Supplier Qualification Program: Implementing a robust program to identify, assess, and approve all critical suppliers.
• Supply Chain Monitoring: Continuously monitoring the performance and compliance of its supplier network.
• Risk Management: Identifying and mitigating potential supply chain risks, such as single-source dependencies, geopolitical instability, or quality issues.

Potential Supply Chain Risks and Mitigation Strategies

The supply chain for any pharmaceutical product carries inherent risks. For LIVMARLI, these risks may include:

• Single-Source API Dependency: Reliance on a single supplier for maralixibat API could create significant vulnerability.
  • Mitigation: Develop relationships with multiple qualified API manufacturers or secure long-term contracts with robust supply commitments. Implement dual-sourcing strategies where feasible.
• Geopolitical Instability: Global sourcing of raw materials and API manufacturing can be affected by international trade disputes, conflicts, or natural disasters.
  • Mitigation: Diversify supplier locations across different geopolitical regions. Maintain buffer stock of critical raw materials and finished goods.
• Quality Control Failures: A quality lapse at any point in the supply chain can lead to product shortages, recalls, and regulatory actions.
  • Mitigation: Implement rigorous supplier qualification and ongoing quality oversight, including frequent audits and robust testing protocols.
• Excipient Shortages: The pharmaceutical industry can experience shortages of specific excipients due to manufacturing issues, increased demand, or regulatory changes.
  • Mitigation: Maintain strong relationships with multiple excipient suppliers. Qualify alternative excipients and suppliers in advance.
• Logistical Disruptions: Delays in transportation, customs issues, or unexpected events can impact timely delivery.
  • Mitigation: Partner with experienced and reliable logistics providers. Utilize diverse transportation modes and routes. Maintain contingency plans for supply chain disruptions.

Key Takeaways

• The synthesis of maralixibat API is complex and requires specialized chemical manufacturing capabilities, with companies like Albemarle, Lonza, Catalent, and WuXi AppTec being potential participants.
• Formulation of LIVMARLI into an oral solution necessitates a range of pharmaceutical-grade excipients from established global suppliers such as BASF, Dow, and Roquette.
• Drug product manufacturing and fill-finish operations likely involve CDMOs with expertise in liquid dosage forms, such as Catalent and Thermo Fisher Scientific.
• Primary and secondary packaging suppliers (e.g., Amcor, Berry Global) and logistics providers are critical for product integrity and distribution.
• Stringent regulatory compliance (cGMP) and robust supplier qualification programs are paramount for Mirum Pharmaceuticals to ensure the quality and safety of LIVMARLI.
• Potential supply chain risks include single-source dependencies, geopolitical instability, quality control failures, excipient shortages, and logistical disruptions, all of which require proactive mitigation strategies.

Frequently Asked Questions

1. Who is the primary manufacturer of maralixibat API? Specific commercial supplier agreements for maralixibat API are not publicly disclosed by Mirum Pharmaceuticals. However, CDMOs with expertise in complex organic synthesis and cGMP manufacturing are likely involved.
2. What are the critical excipients used in LIVMARLI oral solution? Critical excipients likely include solvents, sweeteners, flavoring agents, preservatives, buffering agents, and viscosity modifiers to ensure stability, palatability, and bioavailability.
3. Are there any known single-source suppliers for key LIVMARLI components? Public information does not definitively identify any single-source suppliers for critical components of LIVMARLI. Mirum Pharmaceuticals, as the sponsor, would be responsible for managing and mitigating single-source risks.
4. What regulatory bodies oversee the suppliers for LIVMARLI? Suppliers are primarily overseen by regulatory bodies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), which enforce cGMP standards.
5. How does Mirum Pharmaceuticals ensure the quality of its suppliers? Mirum Pharmaceuticals employs a comprehensive supplier qualification program that includes rigorous audits, quality agreements, and ongoing monitoring of supplier performance and compliance.

Citations

[1] Mirum Pharmaceuticals. (n.d.). LIVMARLI® (maralixibat) Oral Solution. Retrieved from https://www.mirumpharma.com/livmarli/

[2] U.S. National Library of Medicine. (n.d.). PubChem Compound Summary for CID 56841265, Maralixibat. Retrieved from https://pubchem.ncbi.nlm.nih.gov/compound/Maralixibat