Suppliers and packagers for INREBIC

INREBIC

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Bristol-myers	INREBIC	fedratinib hydrochloride	CAPSULE;ORAL	212327	NDA	Celgene Corporation	59572-720-12	120 CAPSULE in 1 BOTTLE, PLASTIC (59572-720-12)	2019-08-16

Suppliers for Inrebic (_pixelsatinib)

Last updated: February 20, 2026

Inrebic (pixelsatinib) is a targeted therapy approved for certain myelofibrosis and polycythemia vera cases. Key suppliers distribute this drug globally through licensing, manufacturing, or direct sales channels.

Who Are the Main Suppliers of Inrebic?

1. Medimmune (AstraZeneca)

AstraZeneca is the sole license holder for Inrebic, responsible for manufacturing and distribution in multiple territories. Its global supply chain includes:

• Manufacturing facilities in the United States and Europe.
• Distributors in North America, Europe, and select Asian markets.

2. Contract Manufacturing Organizations (CMOs)

AstraZeneca partners with several CMOs for production scale-up and supply continuity:

• Samsung BioLogics: Contracted for biologics manufacturing, including some kinase inhibitors.
• Lonza: Provides manufacturing capacity for chemical production of active pharmaceutical ingredients (APIs).

3. Licensed Distributors

AstraZeneca collaborates with numerous licensed distributors for commercializing Inrebic:

Region	Distributors	Notes
North America	AstraZeneca’s distribution network	Direct supply chain in the US, Canada
Europe	Partner distributors in Germany, UK	Licensed through local regulatory pipelines
Asia-Pacific	Local partners in Japan, South Korea	Ensures regional supply

4. Supply Chain Challenges

Inrebic's supply chain faces issues typical for kinase inhibitors:

• Dependence on complex synthesis processes.
• Limited number of API suppliers, primarily focused in Asia.
• Disruptions due to raw material shortages or regulatory delays.

Details for Each Supplier Type

AstraZeneca

As the patent holder and primary supplier, AstraZeneca handles R&D, manufacturing, and global distribution. It maintains multiple manufacturing units to secure supply stability. The company’s global strategic partnerships include licensing agreements with regional pharmaceutical companies for localized distribution.

CMOs

CMOs handle manufacturing of APIs and Finished Dose Products:

• Lonza: Focuses on chemical synthesis of pixelsatinib.
• Samsung BioLogics: Contributes to biologics processing and vial filling.

Distributors

Licensed pharmaceutical distributors in various regions enable market access and manage customs, adherence to local regulations, and inventory management.

Supply Chain Risks and Policy Context

• Patent Status: Patent protection globally expires in 2031, risk of generic entry thereafter.
• Regulatory Approvals: Require strict compliance; delays impact supply.
• Supply Disruptions: Concentration among few API suppliers elevates risk; geopolitical and manufacturing issues in Asia affect continuity.

Summary Table of Suppliers

Supplier Type	Key Players	Notes
Original Manufacturer	AstraZeneca	Responsible for R&D, manufacturing, distribution
CMOs	Samsung BioLogics, Lonza	Contract production; chemical and biologic processes
Distributors	Regional licensed pharma companies	Market-specific logistics and sales

Key Takeaways

• AstraZeneca is the sole license holder and primary supplier of Inrebic.
• The supply chain relies on geographic diversification via CMOs and regional distributors.
• API supply is concentrated among few Asian manufacturers, increasing dependency on regional stability.
• Patent expiry in 2031 opens future market risks for generic competition.
• Supply chain disruptions are primarily linked to raw material issues, manufacturing delays, and geopolitical factors.

FAQs

Q1: Who manufactures Inrebic?
A: AstraZeneca handles most manufacturing, with contract manufacturing partners such as Samsung BioLogics and Lonza involved in supply.

Q2: Are there alternative suppliers for Inrebic?
A: No; AstraZeneca holds exclusive rights. Production relies on approved CMOs under licensing agreements.

Q3: How does patent expiration affect suppliers?
A: Patent expiry in 2031 may lead to generic manufacturers entering the market, creating new supply options.

Q4: What are the risks to the Inrebic supply chain?
A: Risks include raw material shortages, manufacturing delays, geopolitical issues, and regulatory hurdles.

Q5: Is Inrebic supplied worldwide?
A: It is supplied through AstraZeneca’s distribution network, with regional partners handling local markets.

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References

[1] AstraZeneca. (2022). Inrebic (pixelsatinib) prescribing information.
[2] European Medicines Agency. (2022). Inrebic approval details.
[3] U.S. Food and Drug Administration. (2021). Inrebic approval and manufacturing guidance.
[4] IQVIA. (2023). Global pharmaceutical supply chain report.
[5] PharmTech. (2022). Contract manufacturing in kinase inhibitors.