Suppliers and packagers for generic pharmaceutical drug: AXITINIB

AXITINIB

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

Suppliers for the Pharmaceutical Drug: AXITINIB

Last updated: July 29, 2025

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Introduction

Axitinib is an orally administered small-molecule tyrosine kinase inhibitor primarily used to treat advanced renal cell carcinoma (RCC). Marketed under the brand name Inlyta, it was developed by Pfizer and approved by the FDA in 2012[1]. As the demand for targeted oncology therapies grows, the supply chain for axitinib has become increasingly strategic for pharmaceutical companies, contract manufacturing organizations (CMOs), and raw material suppliers. This report examines key suppliers for axitinib, focusing on active pharmaceutical ingredient (API) manufacturing, excipient sourcing, and formulation components.

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Active Pharmaceutical Ingredient (API) Suppliers

1. Contract Manufacturers (CMs) of Axitinib API

The production of axitinib API involves complex synthetic chemistry requiring high purity and stringent quality controls. Multiple pharmaceutical CDMOs globally specialize in API manufacturing for oncology drugs, including axitinib.

• Hospira (Regeneron) / Pfizer's Manufacturing Partners: Initially, Pfizer outsourced the production of axitinib API to third-party manufacturers, including high-volume CMOs in China and India, known for their capacity in complex chemical processes. While Pfizer maintains some in-house manufacturing, it relies heavily on external suppliers for large-scale API production.

• WuXi AppTec: Based in China, WuXi offers comprehensive CMO services, including API synthesis of oncology compounds like axitinib[2]. WuXi's facilities are inspected by global regulatory agencies and possess requisite certifications, making it a key supplier in the global supply chain.

• Siegfried Holding AG: Switzerland-based Siegfried provides custom synthesis and manufacturing services for small-molecule APIs, including targeted therapy compounds similar to axitinib[3]. Their facilities are cGMP-compliant, serving global clients.

• Therapex: Though less prominent, Therapex (India) supplies APIs for oncology drugs and is certified by WHO-GMP, aiming to provide cost-effective APIs to emerging markets.

2. Raw Material Suppliers

Raw materials such as specialized chemical intermediates are critical in axitinib synthesis. Several suppliers provide these intermediates:

• Cambridge Isotope Laboratories: Supplies isotopically labeled intermediates used in analytical validation but also provides precursor chemicals.

• Sigma-Aldrich / MilliporeSigma: Offers various chemical building blocks, including intermediates used in axitinib synthesis.

• Toronto Research Chemicals: Provides high-purity intermediates and reagents necessary for the synthesis pathway.

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Excipients and Formulation Components Suppliers

While the API is the core active component, excipients such as fillers, binders, disintegrants, and coatings are sourced globally.

• DOW Chemicals: Supplies excipients such as silicon dioxide and other inert fillers.

• Colorcon: Known for coating agents and disintegrants used in tablet formulations, ensuring stability and bioavailability[4].

• BASF: Supplies various pharmaceutical excipients, including solubilizers and plasticizers.

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Regulatory and Quality Standards

Suppliers of axitinib API and components adhere to stringent regulatory standards, including:

• cGMP compliance to meet FDA, EMA, and other international standards.
• ISO certifications, such as ISO 9001, ensuring overall quality management.
• Pre-approval inspections by regulatory agencies, verifying manufacturing practices.

These standards are pivotal as they influence the quality, safety, and efficacy of the final product, which is critical in oncology therapies.

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Market Dynamics and Procurement Trends

1. Geographical Shifts

While initially concentrated in Europe and North America, manufacturing has increasingly moved to Asia, especially China and India, driven by lower costs and regulatory flexibilities. Suppliers like WuXi and other Indian API producers now dominate the supply landscape.

2. Patent and Exclusivity

Pfizer currently holds exclusive rights to axitinib for certain jurisdictions. However, generic manufacturers are actively developing similar compounds, which impacts supply dynamics and pricing strategies.

3. Supply Chain Risks

High dependency on a few suppliers magnifies risks related to geopolitical issues, regulatory delays, or quality problems. Diversification strategies are critical to ensure continuous supply, especially amid global disruptions such as the COVID-19 pandemic.

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Emerging Trends and Future Outlook

• Vertical Integration: Some pharmaceutical companies are moving toward in-house API production to enhance supply security.
• Technological Innovations: Advanced synthesis methods, including green chemistry approaches, are being adopted to improve yields and reduce costs.
• Supply Chain Transparency: Increased demand for traceability and verification of raw materials to meet regulatory requirements and ensure patient safety.

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Key Takeaways

• Global Supply Network: The axitinib supply chain is characterized by a diverse network of CMOs, predominantly located in China and India, that manufacture high-quality APIs compliant with international standards.
• Strategic Supplier Relationships: Pharmaceutical companies rely on trusted suppliers like WuXi AppTec, Siegfried, and Therapex to mitigate risk and ensure consistent quality.
• Regulatory Compliance: Adherence to cGMP and other quality standards remains a critical criterion for supplier selection.
• Market Dynamics: Asia's manufacturing capability continues to dominate the supply landscape, fostering competitive pricing and innovation.
• Supply Chain Resilience: Diversification and technological advancements are essential for ensuring uninterrupted supply amid geopolitical and health crises.

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FAQs

1. Who are the leading API manufacturers for axitinib globally?
Major API manufacturing partners include WuXi AppTec (China), Siegfried (Switzerland), and Indian manufacturers such as Therapex, all adhering to high regulatory standards. These firms provide scalable, high-purity axitinib APIs for global markets.

2. Are there any approved domestically produced suppliers for axitinib in the United States or Europe?
Currently, Pfizer and select authorized manufacturers produce axitinib API under strict regulatory compliance. However, most supply is sourced through international CMOs, with limited domestic production due to the molecule's complexity.

3. How do raw material suppliers influence the quality and cost of axitinib production?
Quality raw materials from reputable suppliers like Sigma-Aldrich and Toronto Research Chemicals directly impact the purity, efficacy, and safety of the API. Cost-effective sourcing balances quality to optimize profitability while complying with regulatory standards.

4. What are the risks associated with reliance on Asian suppliers for axitinib API?
Risks include geopolitical tensions, regulatory discrepancies, supply chain disruptions, and intellectual property concerns. Diversification and rigorous quality assurance protocols mitigate these risks.

5. What future trends could affect the supply landscape of axitinib?
Advancements in green chemistry, increased vertical integration, and heightened regulatory scrutiny could reshape supplier strategies. Additionally, emerging biosimilar or generic competitors might alter the market dynamics.

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References

[1] U.S. Food and Drug Administration. Inlyta (Axitinib) Tablets. 2012.
[2] WuXi AppTec Corporate Website. API Manufacturing Services.
[3] Siegfried Holding AG. Contract Manufacturing and API Production.
[4] Colorcon. Excipients for Pharmaceutical Formulations.