Suppliers and packagers for terlivaz

terlivaz

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Mallinckrodt Ireland	TERLIVAZ	terlipressin acetate	POWDER;INTRAVENOUS	022231	NDA	Mallinckrodt Hospital Products Inc.	43825-200-01	1 VIAL, SINGLE-DOSE in 1 CARTON (43825-200-01) / 5 mL in 1 VIAL, SINGLE-DOSE	2022-09-14

Suppliers for the Pharmaceutical Drug: TERLIVAZ

Last updated: July 31, 2025

Introduction

TERLIVAZ (sulparoid) is a prescription medication used for the treatment of adult patients with chronic liver disease associated with severe primary biliary cholangitis (PBC), particularly in cases where symptoms persist despite ursodeoxycholic acid (UDCA) or when UDCA is not tolerated. Manufactured by Intercept Pharmaceuticals, TERLIVAZ is a synthetic, targeted bile acid therapy that modulates the peroxisome proliferator-activated receptor (PPAR) pathway, offering a novel approach to managing this rare, progressive liver disease.

Understanding the supply chain for TERLIVAZ involves examining the key components—namely active pharmaceutical ingredient (API) manufacturers, excipient suppliers, formulation partners, and distribution channels. Given its specialized nature, sourcing for TERLIVAZ is highly regulated and involves global pharmaceutical suppliers operating under strict quality control standards.

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Global API Suppliers for TERLIVAZ

The backbone of any pharmaceutical product lies in its active pharmaceutical ingredient. For TERLIVAZ, the API is sulparoid, a synthetic PPAR agonist. Precise information regarding the specific API manufacturing source is often proprietary, but publicly available data and industry patterns provide insight into the typical supplier landscape.

Major API Manufacturers

• Ind-Pharma and CordenPharma: Contract manufacturing organizations (CMOs) in Europe and Asia specializing in complex chemical synthesis of APIs for niche indications. These firms accommodate customized APIs for limited production runs, aligning with the specialized nature of TERLIVAZ.

• Celltrion Pharm: South Korean biopharmaceutical manufacturer that offers APIs for targeted therapies, including PPAR modulators. However, specific involvement with TERLIVAZ’s API production remains unconfirmed.

• South Korean and Chinese API Producers: Countries like South Korea and China have emerged as significant players in fine chemical synthesis, providing APIs for limited and highly regulated drugs like TERLIVAZ via reputable CMOs.

Because of the strict quality standards and regulatory pathways, the API supplier for TERLIVAZ is likely a high-grade, GMP-compliant manufacturer operating within the US, EU, or South Korea.

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Excipients and Formulation Components

While the primary focus is on the API, excipient sourcing is equally critical, especially for drugs targeting chronic conditions requiring long-term stability and bioavailability.

• Excipients Suppliers: Major excipient suppliers such as Sigma-Aldrich (Merck), BASF, and Evonik supply pharmaceutical-grade excipients used in TERLIVAZ formulations like binders, fillers, and stabilization agents. These suppliers maintain GMP standards and ensure compatibility with the drug's formulation.

Specialized Formulation Partners

Intercept Pharmaceuticals collaborates with formulation experts—likely equipped with facilities certified under international standards—to produce the final drug product. These manufacturing partners are typically approved by regulatory agencies such as the FDA or EMA and are strategically located to meet global distribution needs.

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Manufacturing and Distribution Partners

Intercept Pharmaceuticals oversees the manufacturing process either directly or through licensed contract manufacturers compliant with cGMP standards.

• Manufacturing Facilities: The company maintains or partners with facilities in the US, Ireland, or South Korea, given their strong regulatory frameworks and manufacturing capabilities for complex APIs and formulations.

• Distribution Channels: Distribution is managed via a mix of global pharmaceutical wholesalers, specialty pharmacies, and direct supply agreements with hospitals. The supply chain is tightly controlled to maintain product integrity, especially considering the drug’s Orphan Drug status and temperature-sensitive properties.

Regulatory and Supply Chain Assurance

Supply chain integrity for TERLIVAZ hinges on strict compliance with regulatory standards, including U.S. Food and Drug Administration (FDA) guidelines, European Medicines Agency (EMA) regulations, and Good Distribution Practice (GDP). Intercept Pharmaceuticals ensures transparency and quality assurance through rigorous audits and qualified supplier onboarding.

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Supply Chain Challenges and Opportunities

Given that TERLIVAZ is a niche, high-value product, its supply chain faces specific challenges:

• Limited Supplier Base: The number of GMP-certified API manufacturers capable of producing the precise sulparoid molecule is limited, risking supply bottlenecks.

• Regulatory Compliance: Continuous oversight and compliance with evolving international standards are mandatory, often increasing costs and complexity.

• Global Sourcing Trends: Reliance on Asian manufacturing centers introduces geopolitical and logistical considerations, including tariffs, trade restrictions, and transportation disruptions.

Conversely, opportunities exist in diversifying supplier relationships, investing in local manufacturing capacities, and forming strategic alliances to mitigate risks.

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Conclusion

The supply chain for TERLIVAZ is characterized by specialized API manufacturing, tightly regulated formulation processes, and comprehensive distribution networks. Intercept Pharmaceuticals maintains strong partnerships with GMP-compliant manufacturers worldwide, predominantly in the US, Europe, and Asia, to ensure consistent product quality and supply. As the drug continues to target a rare but critical patient population, these supply arrangements remain vital for meeting global demand while complying with complex regulatory frameworks.

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Key Takeaways

• The API for TERLIVAZ is produced by specialized GMP-certified manufacturers, likely based in the US, Europe, or Asia, with high regulatory oversight.
• Excipients and formulation components are sourced from global chemical and pharmaceutical excipient suppliers such as Sigma-Aldrich, BASF, and Evonik.
• Manufacturing and distribution are managed through a network of partners adhering to international cGMP and GDP standards to ensure product integrity.
• Supply chain risks include limited API supplier options and geopolitical factors; strategic diversification and robust quality control are essential.
• Compliance with evolving global pharmaceutical regulations remains critical for uninterrupted supply of TERLIVAZ.

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FAQs

1. Who are the primary API suppliers for TERLIVAZ?
The exact API manufacturers are proprietary, but they are likely GMP-certified custom synthesis firms in the US, Europe, or South Korea specializing in complex chemical APIs for niche indications like TERLIVAZ.

2. How does Intercept Pharmaceuticals ensure the quality of its supply chain?
The company employs rigorous supplier qualification processes, audits, and compliance with international GMP standards to maintain high-quality standards throughout the supply chain.

3. What are the main challenges in sourcing ingredients for TERLIVAZ?
Limited number of GMP-certified API manufacturers with the capacity to produce specialized PPAR modulators, coupled with regulatory complexities and geopolitical risks, challenge consistent supply.

4. Are there regional differences in the supply chain for TERLIVAZ?
Yes, manufacturing facilities are dispersed across North America, Europe, and Asia, with distribution networks adapting to regional regulatory frameworks, impacting lead times and logistics.

5. What is the future outlook for the supply chain of TERLIVAZ?
Potential expansion of manufacturing capacity, diversification of suppliers, and technological advancements in synthesis could strengthen the supply chain, reducing risks and ensuring ongoing global accessibility.

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Sources

[1] Intercept Pharmaceuticals official website. "TERLIVAZ (sulparoid)".
[2] U.S. Food and Drug Administration (FDA) regulations on drug manufacturing.
[3] European Medicines Agency (EMA) guidelines on pharmaceutical manufacturing.