Suppliers and packagers for viberzi

viberzi

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Abbvie	VIBERZI	eluxadoline	TABLET;ORAL	206940	NDA	Allergan, Inc.	61874-075-08	1 BLISTER PACK in 1 CARTON (61874-075-08) / 8 TABLET, FILM COATED in 1 BLISTER PACK	2015-10-01
Abbvie	VIBERZI	eluxadoline	TABLET;ORAL	206940	NDA	Allergan, Inc.	61874-075-60	1 BOTTLE in 1 CARTON (61874-075-60) / 60 TABLET, FILM COATED in 1 BOTTLE	2015-10-01
Abbvie	VIBERZI	eluxadoline	TABLET;ORAL	206940	NDA	Allergan, Inc.	61874-100-08	1 BLISTER PACK in 1 CARTON (61874-100-08) / 8 TABLET, FILM COATED in 1 BLISTER PACK	2015-10-01

Suppliers for the Pharmaceutical Drug: Viberzi (Eluxadoline)

Last updated: July 29, 2025

Overview of Viberzi

Viberzi (Eluxadoline) is a prescription medication developed by Pfizer, primarily used to treat irritable bowel syndrome with diarrhea (IBS-D). Approved by the FDA in 2015, Viberzi is a mu-opioid receptor modulator that helps reduce bowel motility and urgency, providing symptomatic relief for patients suffering from IBS-D. The drug's manufacturing and supply chain involve complex interactions among raw material providers, active pharmaceutical ingredient (API) producers, excipient suppliers, and finished drug manufacturers.

Understanding the supplier landscape for Viberzi is critical for stakeholders evaluating production costs, regulatory compliance, supply chain resilience, and potential risks related to global sourcing. This article breaks down the key players in supply channels, the sourcing of raw materials, production bottlenecks, and competitive landscape insights.

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Active Pharmaceutical Ingredient (API) Suppliers for Viberzi

Eluxadoline API Production

The core of Viberzi's formulation, eluxadoline, is a synthetic small molecule with a complex synthesis pathway. As a specialty API, its production demands high-level chemical synthesis expertise, strict quality controls, and compliance with Good Manufacturing Practices (GMP).

Most of the API for Viberzi is procured from a limited pool of specialized chemical manufacturers, often located in regions with advanced chemical synthesis capabilities, including Europe and Asia.

Leading API Suppliers:

• CordenPharma: A major provider of high-quality APIs, CordenPharma operates facilities dedicated to complex chemistry and sterile API production in Europe and North America. They supply APIs to multiple global pharmaceutical clients, including Pfizer, possibly including the API for Viberzi.

• Siegfried AG: This Swiss-based biotech firm specializes in contract manufacturing and formulation services, including complex API synthesis. Their capabilities in peptide and small molecule APIs position them as a potential supplier or collaborator.

• Aenova Group: With extensive operations in Europe, Aenova produces APIs and formulations. Their vertically integrated manufacturing might serve as an API source, especially for smaller-scale batches.

• Foreign Asia-based API Manufacturers: Chinese and Indian API producers, such as Hansen Pharmaceuticals and Zhejiang Huahai Pharmaceutical, are known for large-scale manufacturing of generic APIs. While specific supply agreements for Viberzi are not publicly disclosed, these regions dominate the API manufacturing landscape due to cost competitiveness.

Supply Chain Considerations

The complexity of eluxadoline synthesis, along with the need for high purity and regulatory approvals, restricts the number of feasible API suppliers. Pfizer's strategic supply chain likely involves multiple backups with dual sourcing from North American/EU suppliers and Asia to mitigate risks associated with geopolitical disruptions, regulatory delays, or manufacturing issues.

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Raw Materials and Excipient Suppliers

Viberzi's formulation relies on specific excipients, such as microcrystalline cellulose, croscarmellose sodium, magnesium stearate, and other filler and binder compounds. Major excipient suppliers include:

• DuPont Nutrition & Health: Supplies microcrystalline cellulose and other excipients with high purity standards.

• JRS Pharma: Provides various disintegrants such as crospovidone.

• Meggle Group: Known for specialized excipients used in oral solid dosage forms.

These excipient suppliers are widespread and typically serve multiple pharmaceutical clients, contributing to supply stability.

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Finished Drug Product Manufacturing and Packaging

Pfizer oversees the final formulation, tablet compression, packaging, and quality assurance processes. Manufacturing may occur at Pfizer’s facilities or through contract manufacturing organizations (CMOs).

Key Contract Manufacturers:

• Catalent Pharma Solutions: A global CMO with extensive experience in solid-dose manufacturing, likely involved in Viberzi’s production.

• Recipharm: Offers formulation, filling, and packaging services for oral DP products [1].

• Patheon (Thermo Fisher Scientific): Has manufacturing sites across North America and Europe specializing in oral solid dose projects.

Pfizer’s global supply chain diversifies manufacturing across geographic regions to ensure uninterrupted supply and compliance with regional regulatory standards.

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Regional & Market-Specific Suppliers

Given the drug’s global reach, Pfizer and its partners engage with various regional suppliers:

• North America: Emphasis on domestic API and excipient sourcing to meet regulatory requirements.

• Europe: Utilization of European API manufacturers to meet stringent EMA standards.

• Asia: Cost-effective sourcing of raw materials and APIs, with key suppliers in India and China, providing competitive alternatives.

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Regulatory and Quality Assurance Implications

Suppliers for Viberzi must adhere to stringent GMP standards and regulatory audits by authorities such as the FDA, EMA, and PMDA. Pfizer’s due diligence involves supplier qualification, continuous monitoring, and risk management to safeguard against supply disruptions and ensure product quality.

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Emerging Trends and Future Outlook

The supply chain for Viberzi may evolve with advances in synthetic chemistry, biotechnological production, or strategic sourcing shifts driven by geopolitical considerations. Increased adoption of continuous manufacturing and digital supply chain monitoring could enhance resilience. Pfizer and other pharmaceutical companies are increasingly prioritizing supply chain transparency, diversified sourcing, and digital traceability.

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Key Takeaways

• Limited API Suppliers: The complex synthesis of eluxadoline restricts the number of high-quality API suppliers, primarily in North America, Europe, and Asia.

• Asia’s Growing Role: Indian and Chinese manufacturers dominate global API production due to cost advantages, though regional regulatory standards influence sourcing choices.

• Diversified Manufacturing: Pfizer employs multiple contract manufacturing and packaging organizations across North America and Europe, ensuring supply chain resilience.

• Regulatory Compliance: Suppliers are subject to strict GMP standards, with ongoing audits critical for maintaining manufacturing authorization.

• Supply Chain Dynamics: The ongoing geopolitical and logistical challenges necessitate flexible, layered sourcing strategies for continued supply of Viberzi.

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FAQs

Q1: Who are the primary manufacturers of the API for Viberzi?
A1: While Pfizer has not publicly disclosed all API suppliers, known entities like CordenPharma and Siegfried AG are likely involved, complemented by API sourcing from Asian producers such as Hansen Pharmaceuticals or Zhejiang Huahai Pharmaceutical.

Q2: What are the main raw materials used in Viberzi manufacturing?
A2: The drug involves high-purity excipients such as microcrystalline cellulose, croscarmellose sodium, magnesium stearate, and other standard excipients for oral solid dosage forms, supplied by global excipient manufacturers.

Q3: How does Pfizer ensure continuity in the supply chain for Viberzi?
A3: Pfizer employs multiple contract manufacturing organizations across regions, maintains strategic supplier relationships, and implements rigorous quality audits and risk management processes.

Q4: Are there risks associated with relying on Asian API suppliers?
A4: Yes, risks include regulatory delays, political disruptions, intellectual property concerns, and supply chain transparency. Pfizer mitigates these through diversification and compliance standards.

Q5: What emerging trends could impact Viberzi's supplier landscape?
A5: Advances in continuous manufacturing, digital supply chain monitoring, and geopolitical shifts could influence sourcing strategies, emphasizing resilience and transparency.

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Sources

1. Thermo Fisher Scientific. Contract Manufacturing Capabilities. Available at: https://www.thermofisher.com/us/en/home/business-us/contract-manufacturing.html
2. Pfizer Inc. Product Information for Viberzi (Eluxadoline).
3. European Medicines Agency. Guideline on Good Manufacturing Practice and Inspection.
4. CordenPharma. Corporate Overview and API Capabilities.
5. Siegfried AG. Contract Manufacturing Services.