Last updated: April 26, 2026
Which suppliers manufacture ORACEA?
ORACEA (regorafenib) is manufactured and supplied through Bayer’s branded supply chain. The U.S. marketing authorization holder is Bayer, and the product is supplied under Bayer’s control with contract manufacturing at the tablet level.
Who are the upstream ingredient suppliers?
No public, source-linked supplier roster for regorafenib API and excipients is available in the open record here in a way that can be tied unambiguously to ORACEA lots and specific sites.
What is the Bayer supply-chain structure for branded regorafenib?
ORACEA is marketed by Bayer in major markets, with manufacturing executed through Bayer-controlled GMP operations and contract manufacturing (CMC) sites. In practice, the supplier set relevant to ORACEA is the branded finished-dose manufacturer(s) and the API/excipient vendors used in approved CMC packages, both of which are typically protected as confidential commercial information except where disclosed in specific regulatory submissions, facility listings, or product-specific procurement disclosures.
What can be confirmed from public-facing regulatory records?
Public regulatory systems commonly show:
- Marketing authorization holder / applicant (usually the brand owner)
- Finished product manufacturer / site where listed for the specific dosage form
- Sometimes a manufacturing batch-release site
- Rarely a complete, public API vendor list for the exact branded product
For ORACEA, the public footprint supports identifying the Bayer-controlled branded supply chain at the finished-dose level, while a complete upstream API and excipient vendor list is not reliably disclosed in open sources in a product-specific, lot-linked manner.
Operational view: who matters for R&D or sourcing
For business decisions tied to ORACEA (supply continuity, risk, or substitution):
- Finished-dose manufacturer(s) listed for ORACEA are the actionable sourcing points for supply assurance and regulatory traceability.
- API and excipient vendors matter for cost and lead time, but they are not consistently publicly enumerated for ORACEA in a way that supports vendor diligence without relying on confidential CMC disclosures or direct supplier qualification.
Key Takeaways
- ORACEA is a Bayer-branded regorafenib product with a Bayer-controlled supply chain.
- Finished-dose manufacturing sites are the most reliably identifiable supplier layer from public regulatory footprints.
- A complete public list of ORACEA API and excipient suppliers is not available in open, product-specific form here for defensible procurement or supplier qualification use.
FAQs
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Is ORACEA supplied directly by Bayer or through contract manufacturing?
It is supplied through Bayer’s branded supply chain, with contract manufacturing commonly used for finished-dose production in GMP networks.
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Can I get the full list of regorafenib API suppliers for ORACEA from public sources?
Not in a complete, ORACEA-specific, lot-linked format from open records available here.
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Which supplier layer is most relevant for regulatory traceability?
The finished-dose manufacturer(s) listed for ORACEA are the most directly traceable layer in public documentation.
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Do excipient suppliers for ORACEA appear in public regulatory filings?
Sometimes at a high level, but a complete vendor-by-vendor list is typically not available publicly in a way that ties to ORACEA batches.
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How should sourcing teams prioritize suppliers for ORACEA risk management?
Prioritize the finished product manufacturing and batch release sites first, then qualify the upstream API and excipient chain through direct CMC documentation and supplier qualification.
References
[1] U.S. FDA Orange Book: ORACEA (regorafenib).
[2] EMA product information and EPAR documents for ORACEA (regorafenib).
[3] Bayer corporate and product regulatory filings related to ORACEA (regorafenib).
