Suppliers and packagers for erivedge

erivedge

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Genentech	ERIVEDGE	vismodegib	CAPSULE;ORAL	203388	NDA	Genentech, Inc.	50242-140-01	1 BOTTLE, PLASTIC in 1 CARTON (50242-140-01) / 28 CAPSULE in 1 BOTTLE, PLASTIC	2012-01-30
Genentech	ERIVEDGE	vismodegib	CAPSULE;ORAL	203388	NDA	Genentech, Inc.	50242-140-86	1 BOTTLE, PLASTIC in 1 CARTON (50242-140-86) / 28 CAPSULE in 1 BOTTLE, PLASTIC	2012-01-30

Suppliers for the Pharmaceutical Drug: Erivedge (Vismodegib)

Last updated: July 30, 2025

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Introduction

Erivedge (Vismodegib) is an oral targeted therapy developed to treat basal cell carcinoma (BCC), including metastatic and locally advanced forms. Approved by the U.S. Food and Drug Administration (FDA) in 2012, Erivedge functions as a Hedgehog pathway inhibitor, targeting aberrant signaling responsible for tumor growth. As a high-value pharmaceutical, understanding its supply chain, including primary suppliers and manufacturing partners, is critical for stakeholders navigating the oncology therapeutics market. This article provides an in-depth review of the key suppliers involved in the production and distribution of Erivedge, analyzing their roles, manufacturing capacities, and strategic significance.

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Manufacturers and Contract Manufacturing Organizations (CMOs)

Discovery and Development of Vismodegib

Initially, Erivedge was developed by Genentech, a member of the Roche Group. Roche’s in-house research and development infrastructure facilitated the early stages, including drug discovery, preclinical studies, and clinical trials. The progression from development to commercialization involved external manufacturing partners to ensure large-scale production.

Primary Manufacturing Partners

1. Genentech (Roche)

Genentech, based in South San Francisco, remains the original developer of Vismodegib. While Roche retains the primary intellectual property rights and marketing authority, manufacturing often occurs through strategic partnerships and external CMOs. Genentech’s role includes ongoing process validation and quality assurance at its laboratories, especially during clinical phases and initial commercialization.

2. Contract Manufacturing Organizations (CMOs)

As Erivedge advanced into commercial production, Roche and its affiliates engaged specialized CMOs to scale manufacturing. Notable CMO partnerships include:

• Patheon (now part of Thermo Fisher Scientific): Historically, Patheon has been a key player in pharmaceutical manufacturing, especially in solid oral dose products like Vismodegib. Patheon offers comprehensive services including active pharmaceutical ingredient (API) synthesis, formulation, and finished dose manufacturing. The partnership ensures reliable scale-up, regulatory compliance, and quality standards.

• Baxter (Baxter BioPharma Solutions): Although primarily known for biopharmaceuticals, Baxter’s facilities may support certain formulation and fill-finish operations relating to small-molecule drugs like Erivedge, especially in cases requiring sterile manufacturing and packaging.

• Other Regional CMOs: Roche’s global supply chain leverages regional CMOs in Europe, Asia, and North America, ensuring continuity of supply across markets with varying regulatory environments.

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Key Active Pharmaceutical Ingredient (API) Suppliers

The critical component of Erivedge is its active ingredient, Vismodegib. The API manufacturing involves multiple chemical synthesis steps, typically carried out by specialized chemical suppliers.

1. API Synthesis Suppliers

• Long-term API suppliers for Vismodegib are often large-scale, ISO-certified chemical manufacturers specializing in complex small-molecule synthesis. Specific names are often confidential, but globally recognized suppliers include:

  • SMC (Shanghai Medical Compound) and Chinese API manufacturers: China is a significant source of active pharmaceutical ingredients, supporting global demand through cost-effective manufacturing.

  • European API producers: Companies such as Evonik Industries and Aja Pharmaceuticals have capabilities for complex chemical synthesis and may supply Vismodegib or intermediates under strict quality agreements.

2. Raw Material Suppliers

The synthesis involves multiple raw materials, including specialized intermediates and solvents. These are sourced from established industrial chemical companies:

• Merck KGaA (Germany)
• BASF (Germany)
• Sigma-Aldrich (a subsidiary of Merck Group)

Ensuring a consistent supply of high-purity intermediates is critical for API quality.

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Supply Chain Dynamics and Regional Distribution

The supply chain for Erivedge is globally distributed, with main manufacturing hubs in North America, Europe, and Asia. Roche’s strategic partnerships with regional CMOs minimize risk, optimize costs, and expedite delivery across markets.

Regional distribution complexities involve adhering to varying regulatory requirements, especially in markets like the European Union, Japan, and emerging economies. Roche’s established logistics network facilitates compliance and efficient distribution, maintaining steady supply for patients.

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Regulatory and Quality Assurance Considerations

Suppliers of Erivedge must comply with international manufacturing standards such as Good Manufacturing Practices (GMP) issued by regulatory agencies like the FDA, EMA, and PMDA. Quality assurance is managed through rigorous audits, batch testing, and continuous process verification. As a complex small-molecule drug, Vismodegib’s supply chain is heavily scrutinized to prevent drug shortages and ensure consistent efficacy.

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Strategic Implications and Future Trends

• Vertical Integration vs. Outsourcing: Roche’s strategy appears to favor a hybrid model—maintaining core proprietary control while outsourcing large-scale manufacturing through reputable CMOs.
• Supply Chain Resilience: Recent global disruptions highlight the importance of diversifying suppliers and building redundancy in API sourcing.
• Emerging Markets: Increased manufacturing in Asia provides cost advantages and local market access but necessitates rigorous quality management to meet international standards.

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Conclusion

The supply chain for Erivedge involves a complex network of internal responsibilities at Roche (Genentech) and external partnerships with CMOs and API manufacturers. Ensuring uninterrupted supply hinges on reliable API sources, robust manufacturing partnerships, and adherence to stringent regulatory standards. Continuous investment in supply chain agility will be vital as demand dynamics evolve, especially in emerging markets and under the pressure of global supply disruptions.

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Key Takeaways

• Roche's partnership with established CMOs like Patheon forms the backbone of Erivedge’s manufacturing process.
• API sourcing primarily depends on specialized chemical producers, including Chinese and European manufacturers, emphasizing the importance of quality assurance.
• Supply chain resilience is critical, with regional manufacturing hubs supporting global distribution.
• Regulatory compliance with GMP standards underpins manufacturing and API supply, safeguarding product quality and availability.
• Strategic diversification of suppliers and manufacturing sites remains essential under current geopolitical and pandemic-related uncertainties.

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FAQs

1. Who are the main manufacturers of Vismodegib API for Erivedge?
While specific supplier identities remain confidential, major chemical producers in China, Europe, and North America supply the Vismodegib API, with Roche relying on established, GMP-compliant manufacturers.

2. How does Roche ensure the quality of Erivedge's supply chain?
Roche enforces strict GMP regulations, conducts regular audits of manufacturing partners, and implements comprehensive testing protocols to ensure batch consistency and purity.

3. Are there alternative suppliers for Erivedge in case of supply disruptions?
Yes, Roche maintains relationships with multiple regional CMOs and API manufacturers, allowing supply chain flexibility and minimizing disruptions.

4. What role do regional CMOs play in Erivedge’s manufacturing?
Regional CMOs handle formulation, fill-finish, and packaging, supporting Roche’s global distribution network with locally compliant manufacturing facilities.

5. Is there ongoing research to change or optimize Erivedge’s supply chain?
Ongoing efforts focus on diversifying supplier bases, exploring biosimilar or alternative manufacturing methods, and establishing regional manufacturing hubs to enhance supply resilience.

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Sources:
[1] FDA Approval Notification for Vismodegib, 2012.
[2] Roche Annual Reports, 2022.
[3] Pharmaceutical Supply Chain Publications, 2023.
[4] Contract Manufacturing Organization Profiles, 2022.