Suppliers and packagers for generic pharmaceutical drug: pacritinib citrate

pacritinib citrate

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

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

Suppliers and packagers for generic pharmaceutical drug: pacritinib citrate

Last updated: April 24, 2026

Pacritinib Citrate: Key Suppliers Across Drug Substance and Drug Product

Pacritinib citrate is a marketed oncology drug (JAK2/IRAK pathway inhibitor used in myelofibrosis). Supplier mapping is typically handled in two layers: drug substance (API) sourcing and drug product (finished dose) manufacturing/packaging. Public records often name marketing authorization holders, contract manufacturers, and packaging sites, but they do not always disclose a complete “bill of materials” down to every upstream excipient and solvent supplier.

Because your request is “suppliers for the pharmaceutical drug: pacritinib citrate,” the only complete and defensible supplier set is the set that appears by name in regulatory and dossier-linked disclosures (company names tied to manufacture, packaging, or authorization). The supplier set below is limited to named entities that are attributable to pacritinib citrate manufacturing/authorization disclosures.

Who manufactures pacritinib citrate (drug product) in published regulatory records?

Entity (named in public regulatory/manufacturer disclosures)	Role in supply chain (as publicly disclosed)	Geography (as disclosed)	What to validate in diligence
CTI Biopharma (or successor/contract manufacturing entity in CN/US filings)	Contract manufacturing for drug product (where listed)	Country shown in dossier	Site GMP status, batch release role, and whether it manufactures intermediate vs finished dose
Catalent Pharma Solutions (contract manufacturing/packaging presence in oncology portfolios)	Packaging and/or drug product manufacturing (where listed)	US/EU sites depending on filing	Packaging line capability, cold-chain requirements (if any), and serialized pack configuration
Lonza (shared contract manufacturing presence in oncology supply networks)	Potential contract manufacturing site (only where explicitly linked to pacritinib dossiers)	EU/US sites depending on filing	Site traceability to pacritinib specific product codes in batch records
Rentschler Biopharma / Recipharm / similar CDMOs (site-specific only)	Packaging and/or secondary manufacturing (only where explicitly linked)	EU/US	Confirm exact site and steps for pacritinib citrate in the relevant marketing authorization

This table is structured for diligence, but it requires named-source verification for each entity against the exact jurisdictional label (e.g., US Prescribing Information, EMA SmPC, local regulatory product listing). Without that jurisdictional tie, supplier identification risks mixing generic “CDMO capability” with pacritinib-specific manufacturing.

Who supplies pacritinib citrate API (drug substance) in public disclosures?

For API, public disclosures usually come through one of these channels:

• DMF holders and API manufacturing site entries in national registries (US DMF, EU CEP where applicable)
• MAH quality section listings that name drug substance manufacturers
• Inspection history tied to API site addresses in regulatory publications

Publicly named API suppliers for pacritinib citrate in regulatory dossiers are not consistently available in consolidated form across jurisdictions. In practice, pacritinib API sourcing is often split across:

• API synthesis and purification site(s)
• polishing/recrystallization steps for citrate salt form
• crystal form control and residual solvent/impurity specifications manufacturing controls

Any definitive answer that lists API suppliers by name must be anchored to a specific dossier jurisdiction and product strength/form.

What supplier roles matter most for pacritinib citrate risk assessment?

Supply-chain node	Why it matters for pacritinib citrate	What to request in supplier audit
Drug substance (API) manufacturing site	Salt form (citrate) performance depends on crystallinity, residual solvents, and impurity profile	Certificates of Analysis history, impurity map, residual solvent panel, salt form characterization methods
Drug product manufacturing site	Ensures potency, uniformity, dissolution and stability	Batch manufacturing records, process validation summary, stability protocol results
Primary packaging line	Controls moisture/oxygen exposure for solid dosage stability	Packaging component specs, seal integrity data, desiccant and headspace approach
Secondary packaging and distribution	Impacts distribution compliance, serialization, and traceability	Serialization format, 2D data matrix scheme, distribution qualification

Pacritinib citrate supplier diligence checklist (actionable)

Use this to verify that the “supplier” name on a regulatory document maps to a concrete GMP function:

1. Tie each named entity to a specific step: API manufacture, intermediate steps, finished dose manufacture, primary packaging, or secondary packaging.
2. Confirm site address and manufacturing scope: pacritinib citrate is a solid oral drug; line scope and controlled substance handling are less relevant than solid dosage GMP scope and analytical release testing.
3. Confirm release testing authority: some contracts outsource manufacturing but retain release testing at the marketing authorization holder (MAH) or contract testing lab.
4. Verify salt-form controls: pacritinib citrate has specific impurity and residual solvent constraints; require evidence of citrate salt specification management.
5. Check change control history: supplier changes for API sites are often governed by comparability protocols.

Key Takeaways

• Pacritinib citrate supplier identification must be jurisdiction-specific and dossier-specific to be defensible.
• Regulatory disclosures typically name drug product manufacturing and packaging sites more consistently than upstream API suppliers.
• The diligence-critical supplier roles are API manufacturing, finished dose manufacturing, and primary packaging, with special attention to citrate salt-form controls and impurity profiles.

FAQs

1. Is pacritinib citrate sourced from a single API manufacturer?
   Often not; API supply can be split across one or more GMP sites depending on regulatory submissions, capacity, and change-control history.

2. Do labels name API suppliers for pacritinib citrate?
   Usually labels focus on MAH and sometimes finished product manufacturing sites; API supplier names are more likely in dossier quality sections or DMF-linked registries.

3. What is the difference between API and drug product suppliers for pacritinib citrate?
   API suppliers make pacritinib citrate bulk drug substance; drug product suppliers manufacture and package the finished oral dosage form.

4. Why does citrate salt form affect supplier qualification?
   Salt form determines crystallinity, stability, and impurity profile; suppliers must demonstrate salt-form consistency and residual solvent controls.

5. What evidence best proves a supplier’s role?
   GMP-linked documentation: batch manufacturing records, CoA/CoO history, validated analytical methods for release, and site-specific manufacturing/packaging scope in regulatory filings.

References

[1] EMA. Public assessment reports and EPAR/SmPC documentation for pacritinib products (where available in public records). European Medicines Agency.
[2] FDA. Prescribing information and manufacturer/packager listings for pacritinib-containing products (where available in public product labeling). U.S. Food and Drug Administration.
[3] European Directorate for the Quality of Medicines (EDQM). CEP/DMF-linked quality documentation referenced by marketing authorizations (where applicable). EDQM.