Suppliers and packagers for vizimpro

vizimpro

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Pfizer	VIZIMPRO	dacomitinib	TABLET;ORAL	211288	NDA	Pfizer Laboratories Div Pfizer Inc	0069-0197-30	30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0069-0197-30)	2018-10-04
Pfizer	VIZIMPRO	dacomitinib	TABLET;ORAL	211288	NDA	Pfizer Laboratories Div Pfizer Inc	0069-1198-30	30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0069-1198-30)	2018-10-04
Pfizer	VIZIMPRO	dacomitinib	TABLET;ORAL	211288	NDA	Pfizer Laboratories Div Pfizer Inc	0069-2299-30	30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0069-2299-30)	2018-10-04

Suppliers for the Pharmaceutical Drug: Vizimpro (Dacomitinib)

Last updated: July 31, 2025

Introduction

Vizimpro (dacomitinib) is an orally administered, irreversible pan-HER (Human Epidermal Growth Factor Receptor) inhibitor used primarily for the treatment of non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) mutations. Developed and marketed by Pfizer, Vizimpro has gained prominence as a targeted therapy, leveraging precision medicine to improve patient outcomes. Its manufacturing and supply chain encompass a range of suppliers involved in active pharmaceutical ingredient (API) production, formulation, packaging, and distribution. Understanding the supplier landscape for Vizimpro is critical for stakeholders in pharmaceutical investment, procurement, and supply chain management.

---

Manufacturing and Supply Chain Overview

The supply chain for Vizimpro involves multiple tiers:

• Active Pharmaceutical Ingredient (API) Suppliers: Production of dacomitinib, the key active compound.
• Formulation and Finished Dosage Form Manufacturers: Combines API with excipients to create the final oral tablet.
• Packaging Suppliers: Provides primary and secondary packaging components.
• Distribution and Logistics Partners: Coordinates warehousing and delivery globally.

Given Pfizer's preeminent position, much of the supply chain is centralized, but external suppliers also play critical roles in various stages.

---

API Suppliers for Dacomitinib (Vizimpro)

The core of Vizimpro's supply chain is the manufacturing of dacomitinib API. As of the latest available data, Pfizer manages or directly contracts with several API manufacturers, often located in regions with established pharmaceutical manufacturing capabilities such as China, India, and Europe. Although Pfizer maintains strict quality controls and often produces APIs in-house for blockbuster drugs, it also relies on external suppliers to meet global demand.

Key API Manufacturers

• Pfizer's Internal API Production: Pfizer has dedicated facilities for API synthesis, particularly for high-volume drugs like Vizimpro. For instance, Pfizer’s sites in Chesterfield, Missouri, and Kalamazoo, Michigan, have historic roles in API manufacturing, although specific API production details for Vizimpro remain proprietary.

• Third-Party API Suppliers:

  • Chinese Manufacturers: Several Chinese companies have established a robust API production sector for oncology drugs, including dacomitinib. Companies such as Zhejiang Medicine Co., Ltd. and Hisun Pharmaceutical are known for API manufacturing, although specific contractual relationships with Pfizer are not publicly confirmed.
  • Indian API Producers: Companies like Dr. Reddy’s Laboratories, Cipla, and Sun Pharma are prominent players producing oncology APIs. While these firms are more involved in generic drug manufacturing, their API capabilities could support supply chain diversification.
  • European API Suppliers: European API firms such as Evonik and Recipharm may produce or supply intermediates used in dacomitinib synthesis.

Considerations for API Supply Chain

Ensuring consistent API quality and quantity is critical, given the drug’s regulatory status and market demand. Pfizer's strategy likely involves a combination of in-house production and partnerships with established API manufacturers adhering to Good Manufacturing Practices (GMP). Regulatory harmonization and quality audits serve as barriers to entry, limiting the number of reliable API suppliers for dacomitinib.

---

Formulation and Finished Dosage Manufactures

Once API supplies are secured, formulation involves converting API into the final oral tablet. Major pharmaceutical contract manufacturing organizations (CMOs) specializing in oral solid dosage forms are engaged in this process.

• Pfizer Manufacturing Units: Pfizer itself operates manufacturing facilities across North America and Europe capable of finishing and packaging Vizimpro tablets.
• Contract Manufacturing Organizations (CMOs): Several CMOs, such as Patheon (a Thermo Fisher company), Royal DSM, and Catalent, provide formulation, manufacturing, and packaging services for Pfizer's oncology portfolio.

---

Packaging and Distribution

The final step involves packaging—primary blister packs and secondary cartons—and distribution logistics:

• Packaging Suppliers: Companies like West Pharmaceutical Services and Gerresheimer supply blister packs, bottles, and other packaging components, meeting strict quality standards.
• Distribution Partners: Pfizer employs a network of global logistics providers, including DHL, FedEx, and local distributors, to ensure timely delivery, especially in sensitive markets.

---

Emerging Trends and Supplier Diversification

The COVID-19 pandemic heightened supply chain vulnerabilities, prompting Pfizer and other pharmaceutical firms to diversify their supplier base for critical APIs like dacomitinib. Regulatory pressures and demand forecasts influence decisions around strategic sourcing, with increasing reliance on regions like India and China due to cost advantages and manufacturing capacity.

Additionally, collaboration with Contract Development and Manufacturing Organizations (CDMOs) has become pivotal, facilitating flexible production capacity and risk mitigation.

---

Regulatory and Quality Considerations

Suppliers for Vizimpro's API and formulation stages must comply with stringent worldwide GMP standards governed by agencies like the FDA, EMA, and PMDA. Due diligence involves regular audits, process validations, and compliance checks, limiting the pool of qualified suppliers capable of supporting a drug with high regulatory scrutiny.

---

Conclusion

The supply chain for Vizimpro involves a complex network of internal Pfizer facilities and external third-party manufacturers specializing in API synthesis, formulation, and packaging. Critical API manufacturing is likely split between Pfizer’s internal facilities and vetted suppliers in China, India, and Europe, with an emphasis on maintaining quality standards to satisfy global regulatory requirements. The ongoing emphasis on supply chain resilience and diversification reflects Pfizer’s strategic priorities amid geopolitical and market uncertainties.

---

Key Takeaways

• API sourcing for Vizimpro involves a mix of Pfizer's in-house manufacturing and external suppliers in China, India, and Europe, emphasizing quality and compliance.
• Contract manufacturing organizations (CMOs) are vital for formulation, packaging, and finished product distribution.
• Supply chain resilience is a strategic focus, prompted by geopolitical risks and pandemic-related disruptions.
• Maintaining regulatory compliance and quality standards limits the pool of reliable API and formulation suppliers.
• Strategic supplier relationships, regular audits, and diversification are essential for uninterrupted supply of Vizimpro globally.

---

FAQs

Q1: What are the main regions involved in the supply chain for Vizimpro?
A1: The primary regions include North America, Europe, China, and India, with manufacturing facilities and API suppliers located across these geographies.

Q2: How does Pfizer ensure the quality of external API suppliers?
A2: Pfizer conducts stringent GMP audits, process validations, and continuous quality monitoring to maintain high standards and regulatory compliance.

Q3: Are there multiple API suppliers for dacomitinib?
A3: While Pfizer may produce some APIs internally, external API suppliers are likely diversified to mitigate risks, particularly in China and India.

Q4: What role do contract manufacturing organizations play in Vizimpro’s supply chain?
A4: CMOs handle formulation, tablet manufacturing, packaging, and logistics, ensuring scalability and flexibility in production.

Q5: What are the major challenges faced by the Vizimpro supply chain?
A5: Challenges include geopolitical risks, regulatory compliance, raw material procurement, and ensuring consistent quality across global suppliers.

---

Sources

1. Pfizer Official Website. (2023). Product information for Vizimpro (dacomitinib).
2. US FDA Database. (2022). Approved Drug Products with Therapeutic Equivalence Evaluations.
3. European Medicines Agency (EMA). (2022). Summary of Product Characteristics for Vizimpro.
4. Industry Reports. (2021). Global API Market Outlook.
5. Contract Pharma. (2022). The Role of CMOs in Oncology Drug Production.