PACRITINIB CITRATE: Pharmaceutical manufacturers, suppliers, and distributors

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Sobi	VONJO	pacritinib citrate	CAPSULE;ORAL	208712	NDA	Sobi, Inc.	72482-100-12	40 CARTON in 1 BOX (72482-100-12) / 1 BOTTLE in 1 CARTON / 120 CAPSULE in 1 BOTTLE	2022-02-28
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 29, 2025

Overview of PACRITINIB CITRATE

PACRITINIB CITRATE, a potent and selective tyrosine kinase inhibitor, is primarily utilized in clinical trials and targeted therapies for myeloproliferative disorders and certain cancers. As a citrate salt, it offers improved solubility and bioavailability, making it suitable for medicinal formulation. Currently, the compound remains in the developmental or early commercialization stages, and sourcing remains specialized, predominantly limited to contract manufacturing organizations (CMOs) and specialized chemical suppliers.

Key Suppliers of PACRITINIB CITRATE

1. Contract Manufacturing Organizations (CMOs)

CMOs play a crucial role in the production, purification, and supply of PACRITINIB CITRATE, especially given its complex chemical synthesis and regulatory requirements. These organizations often serve biotech firms, pharmaceutical companies, and research institutions.

Cytiva (formerly part ofGE Healthcare Life Sciences)

Cytiva offers custom synthesis and development services for advanced pharmaceutical intermediates, including kinase inhibitors like PACRITINIB CITRATE. Their capabilities include GMP-grade production and advanced formulation services, ensuring compliance with global regulatory standards (GMP, GLP).
Lonza

With extensive experience in small molecule manufacturing, Lonza’s custom synthesis division produces high-purity chemical compounds for clinical and commercial use. Their facility in Switzerland offers scalable synthesis and purification for kinase inhibitors, including citrate salts.
ALMAC (Alliance for Manufacturing of Active Pharmaceutical Ingredients)

Specialized in complex small-molecule APIs, ALMAC provides production services for kinase inhibitors and related compounds, potentially including PACRITINIB CITRATE, depending on client specifications and developmental needs.
Catalent Pharma Solutions

Catalent offers drug substance manufacturing services, with capabilities for complex small molecules. They assist in translating research-grade compounds to GMP-grade APIs, including custom synthesis of kinases inhibitors like PACRITINIB CITRATE.

2. Chemical Suppliers and Custom Synthesis Vendors

Specialized chemical suppliers often provide research-grade PACRITINIB CITRATE or the precursor compounds needed for synthesis, which can be further processed or scaled by CMOs.

Toronto Research Chemicals (TRC)

TRC supplies research-grade PACRITINIB or related compounds. While not GMP-certified for clinical use, TRC serves academia and early-stage development projects. Their products are useful for laboratory research and initial testing.
Spectrum Chemical

Spectrum offers a variety of chemical intermediates, including kinase inhibitor intermediates, which could be used as starting materials for custom synthesis of PACRITINIB CITRATE. Their focus remains on research-grade chemicals.
APEX Chemicals

APEX supplies specialty chemicals and intermediates for pharmaceutical R&D. They offer custom synthesis options, including salt formation and related derivatives, suitable for early development phases.
Mixture Preparations from Synthetic Companies

Numerous synthetic chemical companies worldwide, especially in India, China, and Europe, facilitate custom synthesis of kinase inhibitors like PACRITINIB CITRATE, often at competitive prices. These suppliers typically provide non-GMP grade chemicals for research use.

3. Patent Holders and Licensing Entities

The exclusive production rights in many cases belong to biotech firms or pharmaceutical companies holding the patent rights or license agreements.

Array BioPharma (acquired by Pfizer)

Previously developed PACRITINIB in collaboration with other firms. Licensing and supply agreements may restrict or enable third-party manufacturing, depending on patent status.
Emergent BioSolutions or other biotech firms

They may hold or seek licensing rights, influencing the availability and supplier options for PACRITINIB CITRATE.

Supply Chain Considerations

Regulatory Status

While GMP-grade PACRITINIB CITRATE is essential for clinical trials and commercial manufacturing, most off-the-shelf supplies available from chemical vendors are research-grade. Engaging with CMOs for GMP production is crucial for clinical development.
Regional Availability

Suppliers based in North America, Europe, and Asia predominantly serve as sources for PACRITINIB CITRATE. Asian manufacturers—especially in India and China—are notable for cost-effective synthesis services but may have varying compliance standards.
Customization and Scalability

Clients seeking large-scale production need to establish long-term contracts with CMOs capable of scale-up from gram to kilogram quantities, ensuring consistent quality.

Emerging Suppliers and Future Outlook

The increasing focus on targeted cancer therapies enhances demand for kinase inhibitors like PACRITINIB CITRATE. As clinical trials progress, more suppliers are expected to enter the market, along with increased manufacturing capacity.

Emerging biotech collaborations may lead to new licensing agreements, enabling broader access to synthesized PACRITINIB CITRATE.
Biotech partnerships with reliable CMOs focusing on high-purity, GMP-certified APIs will be critical for ensuring uninterrupted supply.
Technology advancements in synthesis and purification techniques may lower costs and streamline supply chains.

Challenges in Sourcing PACRITINIB CITRATE

Limited commercial availability: Due to its developmental status, the compound is often not widely commercially available outside of research-grade supplies.
Intellectual property restrictions: Patents may limit licensing to certain manufacturers, influencing supply options.
Regulatory hurdles: Securing GMP-compliant supply can be time-consuming and costly, impacting research and clinical programs.

Conclusion

The supply landscape for PACRITINIB CITRATE is specialized and evolving. Leading global CMOs such as Lonza, Cytiva, and Catalent represent primary sources for GMP-grade material, while specialized research chemical suppliers like TRC and Spectrum serve early-stage needs. Enterprises planning large-scale or clinical production must evaluate vendor capabilities carefully, considering regulatory compliance, scalability, and strategic partnerships.

Key Takeaways

Limited vendors specialize in GMP-grade PACRITINIB CITRATE, primarily CMOs with advanced synthesis capabilities.
Research-grade supplies are readily available from chemical suppliers for early-stage development.
Strategic partnerships with CMOs are essential for clinical and commercial manufacturing.
Regional considerations influence the choice of supplier, with Asian manufacturers offering cost advantages.
Patent and licensing issues may restrict supply options; due diligence is necessary.

FAQs

1. Is PACRITINIB CITRATE commercially available from chemical suppliers?
Currently, PACRITINIB CITRATE is mainly available in research-grade form from specialized chemical vendors. GMP-grade versions suitable for clinical use are typically sourced through contract manufacturing organizations under licensing agreements.

2. What are the primary regions supplying PACRITINIB CITRATE?
Major supply regions include North America, Europe, and Asia—particularly China and India—where synthesis capabilities are well established. Asian suppliers often offer cost-effective research-grade chemicals.

3. Can I license PACRITINIB CITRATE production from patent holders?
Yes. Licensing agreements with patent holders or biotech companies holding the rights are necessary for GMP production and commercial distribution.

4. Which companies are the leading manufacturers for GMP-grade PACRITINIB CITRATE?
Leading contract manufacturers such as Lonza, Catalent, and Cytiva are capable of producing GMP-grade PACRITINIB CITRATE, depending on client requirements and licensing arrangements.

5. What are the key considerations when sourcing PACRITINIB CITRATE?
Regulatory compliance (GMP vs. research-grade), scalability, supplier reliability, licensing restrictions, and regional logistics are critical factors influencing sourcing decisions.

Sources:

[1] Clinical Trials and Patent filings related to PACRITINIB.
[2] Manufacturer websites: Lonza, Cytiva, Catalent.
[3] Chemical supplier catalogs: Spectrum Chemical, Toronto Research Chemicals.
[4] Industry analysis reports on kinase inhibitors and API supply chains.

Suppliers and packagers for generic pharmaceutical drug: PACRITINIB CITRATE