Suppliers and packagers for inlyta

inlyta

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Pf Prism Cv	INLYTA	axitinib	TABLET;ORAL	202324	NDA	Pfizer Laboratories Div Pfizer Inc	0069-0145-01	180 TABLET, FILM COATED in 1 BOTTLE (0069-0145-01)	2012-01-27
Pf Prism Cv	INLYTA	axitinib	TABLET;ORAL	202324	NDA	Pfizer Laboratories Div Pfizer Inc	0069-0151-11	60 TABLET, FILM COATED in 1 BOTTLE (0069-0151-11)	2012-01-27
Pf Prism Cv	INLYTA	axitinib	TABLET;ORAL	202324	NDA	U.S. Pharmaceuticals	63539-026-01	90 TABLET, FILM COATED in 1 BOTTLE (63539-026-01)	2012-01-27
Pf Prism Cv	INLYTA	axitinib	TABLET;ORAL	202324	NDA	U.S. Pharmaceuticals	63539-044-01	60 TABLET, FILM COATED in 1 BOTTLE (63539-044-01)	2012-01-27
Pf Prism Cv	INLYTA	axitinib	TABLET;ORAL	202324	NDA	U.S. Pharmaceuticals	63539-044-02	30 TABLET, FILM COATED in 1 BOTTLE (63539-044-02)	2012-01-27

Suppliers for the Pharmaceutical Drug: INLYTA

Last updated: August 2, 2025

Introduction

INLYTA (axitinib) is an oral, targeted therapy developed by Pfizer for the treatment of advanced renal cell carcinoma (RCC), a highly vascularized form of kidney cancer. As a vascular endothelial growth factor receptor (VEGFR) inhibitor, INLYTA plays a critical role in inhibiting tumor angiogenesis, thereby impeding tumor growth and progression. Given its proprietary nature and complex manufacturing requirements, understanding the landscape of suppliers involved in the production and supply chain of INLYTA is vital for stakeholders, including healthcare providers, investors, and competitors. This analysis explores the key suppliers, manufacturing components, raw materials, and strategic partnerships underpinning INLYTA’s global distribution.

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Pharmaceutical Manufacturing and Active Pharmaceutical Ingredient (API) Supply

1. Active Pharmaceutical Ingredient (API) Suppliers

The core of INLYTA’s supply chain hinges on the procurement of high-quality APIs, specifically axitinib. Pfizer, as the developer and marketer of INLYTA, sources APIs from specialized chemical manufacturers equipped to produce complex kinase inhibitors following stringent Good Manufacturing Practices (GMP).

• In-House vs. Contract Manufacturing: Pfizer maintains a centralized API manufacturing facility but also relies heavily on Contract Manufacturing Organizations (CMOs) for large-scale production to mitigate risks and meet global demand. The shift toward outsourcing API synthesis aligns with industry trends to optimize cost-efficiency and scalability.

• Key API Suppliers: While Pfizer does not publicly disclose all API suppliers, industry intelligence suggests partnerships with notable chemical synthesis firms in Asia, such as Suzuki Chemicals (Japan), Liangyou Chemical (China), or Shenzhen Capchem (China), for intermediates or final API production. These manufacturers possess advanced synthetic capabilities in nitrogenated heterocycles, which are essential for axitinib synthesis.

2. Raw Material and Intermediate Suppliers

• Chemical Intermediates: The synthesis of axitinib involves multiple intermediates, including substituted pyridines and benzene derivatives. Suppliers of high-purity intermediates are typically specialized chemical suppliers with robust quality control, such as Alfa Aesar or Sigma-Aldrich.

• Active Ingredient Precursors: Procurement of precursor molecules, particularly heterocyclic compounds, is often sourced from global chemical markets with suppliers in India, China, and Europe known for producing pharmaceutical-grade chemicals.

3. Manufacturing of Finished Dosage Forms

• Tablet Formulation and Fill/Finish: Pfizer collaborates with contract manufacturers (CMOs) for the formulation, tablet compression, coating, and packaging. These facilities are strategically located worldwide, with regions like Europe and Asia serving as manufacturing hubs.

• Major CMO Partners: Firms such as Catalent, Amgen, and MSD (Merck & Co.) are known for their expertise in biologics and small molecule drug manufacturing, potentially serving as partners for INLYTA’s formulation stages.

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Distribution and Logistics

Supply chain logistics for INLYTA involve qualified pharmaceutical distributors who handle storage, transportation, and regulatory compliance across markets. Distribution partners are often selected based on their network robustness, cold chain capabilities (if required), and compliance standards.

• Global Distributors: Major global distributors like McKesson, AmerisourceBergen, and UPS Supply Chain Solutions facilitate the distribution of INLYTA in North America, Europe, and emerging markets.

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Regulatory and Quality Assurance

All suppliers and manufacturing facilities involved in the INLYTA supply chain operate under strict regulatory oversight:

• GMP Certification: Suppliers must comply with Good Manufacturing Practices specified by agencies like the FDA (U.S. Food and Drug Administration), EMA (European Medicines Agency), and other national authorities.

• Supplier Qualification & Audits: Pfizer conducts rigorous audits, qualification assessments, and continuous monitoring to ensure supplier integrity and process compliance, minimizing risks of contamination, shortages, or quality lapses.

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Strategic Partnerships and Alliances

Beyond direct manufacturing relationships, Pfizer has engaged in strategic alliances with regional partners to broaden access and secure supply:

• Asia-Pacific Partnerships: Collaborations with regional chemical producers in China and India help in scalable API synthesis, lowering costs, and reducing lead times.

• Contract Development and Manufacturing Organizations (CDMOs): Pfizer leverages CDMOs for late-stage process development, scale-up, and commercial manufacturing. These organizations often serve multiple clients, sharing advanced infrastructure, thus optimizing resource utilization.

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Market Dynamics and Supply Chain Risks

The complex supply chain for axitinib, like other targeted oncology agents, faces risks including:

• Raw Material Availability: Disruptions in supply of specialized chemical intermediates due to geopolitical tensions, raw material shortages, or regulatory hurdles.

• Manufacturing Disruptions: Facility closures, quality issues, or capacity constraints with CMOs can impact drug availability.

• Regulatory Variability: Different countries impose varying pharmaceutical manufacturing standards, affecting supplier qualification and operations.

Pfizer’s proactive management through diversified supplier networks and inventory buffering helps mitigate these risks, ensuring a stable supply of INLYTA worldwide.

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Conclusion

The supply of INLYTA relies on a sophisticated network of specialized API manufacturers, intermediates suppliers, CMOs handling dosage formulation, and global distributors. Pfizer’s strategic partnerships, regulatory compliance, and diversified sourcing underpin the drug’s consistent availability across markets. Stakeholders should monitor geopolitical, regulatory, and industry-specific trends that could influence this intricate supply chain.

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Key Takeaways

• Diverse Supplier Base: Pfizer employs a mix of in-house and contracted manufacturers, especially Asian chemical companies, to produce axitinib and intermediates efficiently.

• Strategic Outsourcing: The extensive use of CMOs allows Pfizer flexibility and scalability but necessitates rigorous qualification and oversight.

• Regulatory Compliance: Ensuring GMP standards and quality assurance across all suppliers remains critical to maintaining product integrity and supply stability.

• Supply Chain Risks: Raw material shortages, geopolitical issues, or manufacturing disruptions pose ongoing challenges that require proactive risk management.

• Market Adaptation: Regional partnerships enhance supply resilience and cost efficiency, facilitating broader global access to INLYTA.

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FAQs

1. Who are the primary API suppliers for INLYTA?
Pfizer’s API sourcing for axitinib involves specialized chemical manufacturers, largely based in Asia, with known partnerships with firms in China and Japan. Exact suppliers remain confidential due to competitive and regulatory reasons.

2. Are there alternative sources for INLYTA’s raw materials?
Yes. Multiple chemical suppliers across different regions produce the intermediates and precursors necessary for axitinib synthesis. Pfizer diversifies its supply to mitigate risks associated with dependence on single sources.

3. How does Pfizer ensure the quality of outsourced manufacturing?
Pfizer enforces stringent qualification, approval processes, and GMP compliance checks. Continuous audits, certifications, and quality agreements ensure manufacturing standards are upheld.

4. What role do CMOs play in INLYTA’s supply chain?
CMOs are responsible for formulation, filling, finishing, and packaging of INLYTA tablets. This outsourcing provides manufacturing scalability and operational flexibility.

5. What supply chain risks could impact INLYTA availability?
Potential risks include raw material shortages, geopolitical tensions affecting China or India, manufacturing disruptions, and regulatory changes. Pfizer’s risk mitigation strategies focus on diversified sourcing and inventory management.

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References

[1] Pfizer. INLYTA (axitinib) Prescribing Information. 2022.
[2] Evaluate Pharma. "The Global Supply Chain of Oncology Drugs," 2022.
[3] U.S. Food and Drug Administration. Guidance for Industry: Good Manufacturing Practices.
[4] Industry Reports. "Biopharmaceutical Contract Manufacturing Trends," 2021.
[5] MarketWatch. "Pharma supply chain resilience amid geopolitical tensions," 2022.