Suppliers and packagers for NEXAVAR

NEXAVAR

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Bayer Hlthcare	NEXAVAR	sorafenib tosylate	TABLET;ORAL	021923	NDA	Bayer HealthCare Pharmaceuticals Inc.	50419-488-58	120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50419-488-58)	2005-12-20
Bayer Hlthcare	NEXAVAR	sorafenib tosylate	TABLET;ORAL	021923	NDA	Bayer HealthCare Pharmaceuticals Inc.	50419-489-01	120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50419-489-01)	2023-10-02

Suppliers and packagers for NEXAVAR

Last updated: May 24, 2026

NEXAVAR (sorafenib) suppliers: who manufactures the drug substance and finished tablets?

NEXAVAR is sorafenib (Nexavar, Bayer). The commercial product is supplied globally by Bayer, while sorafenib API and tablet manufacturing have historically involved multiple contract manufacturing organizations (CMOs) under Bayer’s drug supply network. No complete, audit-grade supplier list (API + finished dosage, by country and site) can be produced from the information provided.

Who are the key suppliers and contract manufacturers for NEXAVAR (sorafenib) tablets?

Featured snippet answer: Bayer supplies Nexavar under its commercial supply chain; site-level tablet manufacturing and packaging suppliers vary by geography and are controlled through Bayer’s network of CMOs and internal sites.

What manufacturing steps do suppliers cover (finished dose)?

• Final tablet manufacture (mixing, granulation, compression)
• Film coating
• Packaging (bottles/blisters), labeling, and distribution release

How do supplier lists typically differ by market?

• US/Canada vs. EU vs. rest-of-world often use different packaging and release sites
• Line clearance, batch record ownership, and QP release roles shift by region

Which companies supply the sorafenib API used to make NEXAVAR?

Featured snippet answer: Sorafenib API suppliers are typically upstream API manufacturers feeding Bayer’s finished-dose supply chain; API source can change with capacity and regulatory approvals.

What does “supplier” mean in API procurement?

• API manufacturer (drug substance production)
• API testing and release (internal QC/QP or delegated testing)
• Supply agreements (long-term supply vs. single-source campaigns)

Why API sourcing changes for long-life products

• Regulatory changes, plant modernization
• Capacity swings and cost optimization
• Post-approval manufacturing changes requiring comparability

What patent estate controls NEXAVAR supply and generic production risk?

Featured snippet answer: NEXAVAR sorafenib is a small-molecule drug; supply and generic risk is primarily governed by Orange Book-listed composition, formulation, and use patents plus any unexpired exclusivity, not by “supplier” identity alone.

How patents affect supply

• Patent-protected processes and formulations can block certain manufacturing routes
• Method-of-use claims can restrict medical indication entry by generics

What is the Orange Book status of NEXAVAR, and how does it affect supply?

Featured snippet answer: Orange Book status determines whether a generic can launch and at what risk level (including Paragraph IV triggers). Supplier changes do not override patent status.

How Paragraph IV filings connect to supply

• If no “at-risk” launch is allowed, demand stays with the branded supply chain
• If allowed, branded demand shifts to competing generics irrespective of who supplies API

When does NEXAVAR lose exclusivity in key markets?

Featured snippet answer: Small-molecule exclusivity is time-limited and patent-expiration driven; the exact end date depends on each jurisdiction’s last relevant patent and exclusivity.

How to time generic and CMO planning

• Track last-to-expire composition-of-matter, then formulation and method-of-use
• Map to each jurisdiction’s patent term adjustments and litigation outcomes

What generic entry risks exist for sorafenib tablets (and how do those risks impact sourcing)?

Featured snippet answer: Generic launch risk influences which API suppliers buyers select and whether supply contracts lock in branded demand.

Typical sourcing responses

• Increased use of qualified secondary API sources ahead of launch windows
• Switching finished-dose CMOs for lower unit cost or faster turnaround
• Tightening QMS, especially around dissolution and polymorph control

How does NEXAVAR manufacturing compare with other sorafenib brands in the same markets?

Featured snippet answer: Competitors generally produce sorafenib tablets to the same strength specifications, but excipient systems, coating recipes, and process parameters can differ, affecting bioequivalence and stability.

What changes most often across brands

• Coating polymer systems and film weight
• Excipients impacting dissolution rate
• Compression and granulation process parameters

Which regulatory approvals define supplier qualification for NEXAVAR?

Featured snippet answer: FDA and other medicines regulators define supplier qualification through cGMP inspection readiness and site approval for the registered manufacturing stages.

What inspectors and regulators look for

• Traceability from raw material to finished batch
• Validated analytical methods for release and stability
• Change control, comparability packages, and remediation history

Key Takeaways

• Nexavar (sorafenib) is supplied under Bayer’s commercial network; site-specific tablet and API supplier identification requires source-grade documentation that is not provided here.
• Patent and Orange Book status govern generic and “at-risk” supply dynamics more than supplier identity.
• Any procurement or licensing plan should separate finished-dose supplier qualification from API drug substance qualification and align both to regulatory site status.

FAQs

1. How do I identify the actual NEXAVAR manufacturing sites listed in regulatory submissions?
2. Are sorafenib API suppliers the same across US and EU Nexavar markets?
3. What manufacturing changes to sorafenib tablets require regulatory notification or approval?
4. How do Paragraph IV challenges affect branded sorafenib supply contracts?
5. What quality attributes are most critical for sorafenib API polymorph and tablet dissolution?

References

1. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. (Accessed 2026-05-25).
2. FDA. Drugs@FDA: Nexavar (sorafenib). (Accessed 2026-05-25).