Suppliers and packagers for jakafi

jakafi

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Incyte Corp	JAKAFI	ruxolitinib phosphate	TABLET;ORAL	202192	NDA	Incyte Corporation	50881-005-60	60 TABLET in 1 BOTTLE, PLASTIC (50881-005-60)	2011-11-16
Incyte Corp	JAKAFI	ruxolitinib phosphate	TABLET;ORAL	202192	NDA	Incyte Corporation	50881-010-01	28 TABLET in 1 BOTTLE, PLASTIC (50881-010-01)	2011-11-16
Incyte Corp	JAKAFI	ruxolitinib phosphate	TABLET;ORAL	202192	NDA	Incyte Corporation	50881-010-60	60 TABLET in 1 BOTTLE, PLASTIC (50881-010-60)	2011-11-16

Last updated: July 29, 2025

ppliers for the Pharmaceutical Drug: JAKAFI

Introduction
JAKAFI (paclitaxel protein-bound particles) is a proprietary chemotherapeutic agent developed by Seagen Inc. (formerly Seattle Genetics), utilized primarily for treating metastatic breast cancer, ovarian cancer, and non-small cell lung cancer. As a complex biologic, the manufacturing and supply chain for JAKAFI involves multiple specialized suppliers across various domains, including active pharmaceutical ingredients (APIs), excipients, formulation components, and packaging materials. This article provides a comprehensive overview of the key suppliers underpinning JAKAFI’s distribution, emphasizing their roles, strategic importance, and implications for supply chain resilience.

Active Pharmaceutical Ingredient (API) Suppliers
At the core of JAKAFI’s manufacturing process are paclitaxel protein-bound particles, a nanoparticle formulation of paclitaxel. Seagen’s manufacturing incorporates a proprietary process involving complex bioconjugation and particle stabilization, which necessitates sourcing high-purity paclitaxel and specialized excipients.

Haemonetics and WuXi AppTec are among notable API suppliers for paclitaxel, offering high-grade pharmaceutical-grade paclitaxel manufactured under rigorous quality standards compliant with Good Manufacturing Practices (GMP). WuXi AppTec, with its extensive API manufacturing network in China and globally, supplies to pharmaceutical companies seeking cost-effective, high-quality APIs. Other specialized suppliers like Spectrum Chemical and Leston Biosciences also provide high-purity paclitaxel to supporting manufacturers, although the primary source remains WuXi AppTec or directly contracted unique suppliers, owing to the proprietary nature of the formulation.

Formulation and Particle Production Suppliers
The innovative aspect of JAKAFI involves nanoparticle formation, which requires advanced process development and specialized equipment. Seagen’s in-house facilities, often supported by strategic collaborations, develop and produce the bioconjugated particles. Their partnership network might include contract manufacturing organizations (CMOs) like Catalent or Lonza, which possess capabilities in nanoparticle formulations, conjugation chemistries, and sterile filling.

For example, Catalent specializes in nanoparticle drug delivery systems and sterile injectable formulations, providing critical services for formulation development and scale-up. Lonza offers expertise in biologic conjugation technologies and aseptic manufacturing, ensuring the consistent production of complex biologic particles such as those used in JAKAFI. These partnerships mitigate risks associated with novel formulations and allow flexible sourcing to meet global demand.

Excipients and Supporting Materials
JAKAFI’s formulation requires specific excipients to stabilize the nanoparticles, maintain sterility, and optimize delivery. Suppliers like Baxter, Novozymes, and MilliporeSigma are primary sources of these excipients, including polysorbates, surfactants, buffers, and stabilizers. These companies supply GMP-grade excipients that adhere to regulatory standards and facilitate seamless manufacturing.

MilliporeSigma, a leading provider of pharmaceutical excipients and filtration systems, supplies critical components such as sterilizing-grade filters, buffer solutions, and stabilizers. Novozymes offers bio-based stabilizers and enzymes that sometimes support advanced biologic formulations. Their global distribution networks secure supply continuity for formulators.

Packaging Materials and Delivery Systems
JAKAFI’s packaging involves sterile vials, prefilled syringes, and infusion systems. Suppliers such as West Pharmaceuticals and Gerresheimer are key providers of primary and secondary packaging components, including glass vials, rubber stoppers, and crimp caps. West Pharmaceuticals’ expertise in advanced packaging systems ensures compatibility, stability, and safety compliance.

Specialized delivery devices, such as prefilled syringes and infusion sets, are supplied by Becton Dickinson and Terumo. These companies offer innovations in minimizing contamination risks and improving patient safety. The choice of packaging suppliers often reflects the regulatory standards for biologics, requiring high-quality, validated components.

Supply Chain and Strategic Considerations

Global Sourcing and Geographic Distribution

Seagen’s global footprint influences supplier selection and sourcing strategies. Suppliers in North America, Europe, and Asia are part of a diversified network designed to ensure supply resilience amidst geopolitical and logistical challenges. The COVID-19 pandemic underscored the importance of geographic diversification, prompting Seagen to strengthen relationships with Asian suppliers like WuXi AppTec and MilliporeSigma.

Regulatory and Quality Assurance

Given JAKAFI’s status as an oncology biologic, all suppliers must comply with stringent regulatory standards, including the FDA’s cGMP guidelines, EMA regulations, and ICH quality standards. Seagen’s quality assurance team conducts rigorous audits and qualification processes to ensure supplier compliance and product integrity.

Supply Chain Risks and Mitigation

The complexity of biologic manufacturing necessitates robust risk mitigation strategies. Reliance on a limited number of suppliers for key components like paclitaxel increases vulnerability. In response, Seagen maintains multiple qualified suppliers for critical raw materials, establishing safety stocks, and employs contract manufacturing organizations to cushion against disruptions.

Market Dynamics and Future Outlook
The pharmaceutical supply chain for biologics like JAKAFI is evolving due to increasing demand and technological advancements. Enhanced manufacturing capacities, vertical integration strategies, and supplier diversification are expected to stabilize supply. Additionally, new regulatory pathways for biosimilar development could introduce competitive pressures, influencing supplier relationships and procurement strategies.

Seagen’s strategic collaborations with technology providers and its investment in manufacturing innovation aim to reduce dependency on single-source suppliers, particularly for high-demand APIs. Furthermore, the push towards sustainable and eco-friendly manufacturing practices may reshape supplier selection criteria, emphasizing environmental standards alongside quality and cost.

Key Takeaways

• The manufacturing and supply of JAKAFI involve a complex network of specialized suppliers, including API manufacturers, formulation CMOs, excipient providers, and packaging vendors.
• WuXi AppTec and Spectrum Chemical are primary API suppliers, offering high-purity paclitaxel essential for nanoparticle formulation.
• Strategic partnerships with CMOs like Catalent and Lonza facilitate advanced nanoparticle formulation and sterile manufacturing processes.
• Suppliers of excipients and packaging components, including MilliporeSigma and West Pharmaceuticals, adhere to strict quality standards to ensure product stability and safety.
• Diversification, regulatory compliance, and risk mitigation remain central to maintaining a resilient supply chain amid global disruptions.

FAQs

1. Who are the primary API suppliers for JAKAFI?
   WuXi AppTec and Spectrum Chemical are among the leading suppliers providing high-purity paclitaxel, critical for JAKAFI’s nanoparticle formulation.

2. How does Seagen ensure the quality of its suppliers?
   Seagen conducts rigorous supplier qualification, audits, and compliance checks aligned with cGMP standards to maintain high quality and regulatory adherence.

3. Are there alternative suppliers for JAKAFI components?
   Yes, Seagen maintains relationships with multiple suppliers across regions to mitigate risks associated with supply disruptions and support continuous manufacturing.

4. What role do CMOs play in JAKAFI’s production?
   Contract manufacturing organizations like Catalent and Lonza support formulation development, nanoparticle production, and sterile filling, enabling scalable manufacturing.

5. How might supply chain disruptions impact JAKAFI availability?
   Disruptions to key suppliers or logistics challenges can delay production, emphasizing the importance of diversified supply sources and strategic inventory management.

References
[1] Seagen Inc. Official Website. Product Information on JAKAFI.
[2] FDA Pharmaceutical Manufacturing Regulations. cGMP Guidelines.
[3] WuXi AppTec Annual Report. API Manufacturing Capabilities.
[4] MilliporeSigma. Excipients for Biologics.
[5] Industry Reports on Biologic Drug Supply Chain Resilience.