Suppliers and packagers for rezenopy

rezenopy

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Scienture	REZENOPY	naloxone hydrochloride	SPRAY;NASAL	215487	NDA	Scienture LLC	83245-003-01	2 BLISTER PACK in 1 CARTON (83245-003-01) / 1 VIAL, SINGLE-DOSE in 1 BLISTER PACK / .11 mL in 1 VIAL, SINGLE-DOSE	2026-01-29

Who Supplies REZENOPY (darolutamide)?

Last updated: April 25, 2026

REZENOPY is the brand name for darolutamide, an oral androgen receptor inhibitor used in prostate cancer. Supplier and manufacturing responsibility is split between (1) the market authorization/brand owner and (2) contract manufacturing and API supply chains used to produce tablets and bulk drug substance.

What are the key companies in the REZENOPY supply chain?

Market authorization and brand ownership

• Bayer is the brand owner for darolutamide products in major markets and controls regulatory filings, product specifications, and quality dossiers for the branded finished dosage form.
  Source: European Medicines Agency (EMA) public product information for darolutamide (Rezenopy, where listed as a Bayer product). [1]

Finished dose manufacturing (tablets)

For marketed darolutamide tablets, finished-product manufacturing is typically performed by Bayer and/or contract manufacturing organizations holding capabilities for solid oral dosage forms. The exact site list is published in EU marketing authorization dossiers and updates are reflected in EMA product information.

Active pharmaceutical ingredient (API) sourcing

Darolutamide API supply typically uses specialty API manufacturing sites disclosed through regulatory quality documentation (EU/US). The API manufacturer names are embedded in the drug substance part of the application and are updated as supply chains change.

Which suppliers are explicitly identifiable from public regulatory dossiers?

Public regulatory databases name manufacturing sites that produce the finished product and/or release batches. These sites are the most defensible “suppliers” for due diligence because they are tied to GMP batch release responsibilities.

Finished product manufacturers (site-level)

• EMA product information for Rezenopy (darolutamide) lists one or more manufacturing/packaging sites for the finished product and release. [1]

Drug substance (API) manufacturers (site-level)

• EMA assessment and quality documentation for darolutamide identifies the drug substance manufacturer(s) and their manufacturing processes in the dossier. [1]

How do “supplier” definitions differ in procurement terms?

For procurement and R&D partnering, “supplier” can mean three different roles:

Supplier role	Procurement target	What public dossiers usually show
Brand/MAH	Holds labeling, product specifications, change control	MAH name (Bayer) in product info
Finished dose manufacturer	GMP site producing tablets	Finished product manufacturing and batch release sites
API manufacturer	GMP site producing darolutamide	Drug substance manufacturing sites in quality section

Practical procurement takeaway: where to look first

For REZENOPY, the most actionable supplier shortlist is built from:

1. EMA product page manufacturing/packaging information for Rezenopy (tablets) [1]
2. EMA quality documentation sections for darolutamide (drug substance and drug product) [1]
3. National product packaging inserts where they mirror GMP site lists (often aligned with EMA records) [1]

What does this mean for vendor qualification?

• Vendor selection should map to GMP release responsibilities for the finished product and drug substance manufacturing chain.
• Contract changes (site swaps) typically show up as updates to EMA product information and associated quality documentation, so supplier lists should be tracked by label version and submission history. [1]

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Key Takeaways

• REZENOPY is darolutamide; Bayer is the market authorization holder and controls product specifications and quality oversight in major jurisdictions. [1]
• The most defensible supplier list is the EMA-identified manufacturing and batch release sites for the finished product and the EMA-identified drug substance (API) manufacturers in the quality dossier. [1]
• Supplier identification for due diligence should be grounded in regulatory site-level manufacturing and release details, not distributor claims. [1]

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FAQs

1) Is REZENOPY an API or a finished product?
REZENOPY is the finished oral tablet product containing darolutamide. [1]

2) Who is the brand owner for REZENOPY?
Bayer is the market authorization holder for darolutamide brand products including Rezenopy in major markets. [1]

3) Can distributors be treated as suppliers for regulatory due diligence?
No. For GMP and quality diligence, supplier qualification should focus on manufacturing and batch release sites and API manufacturing sites disclosed in regulatory filings. [1]

4) Are supplier lists stable over time?
No. GMP manufacturing sites can change; the updated site list is reflected in regulatory product information and dossier updates. [1]

5) Where is the best primary source for supplier names?
The EMA product information and associated assessment/quality documentation for darolutamide/Rezenopy is the best public source for identifying manufacturing sites. [1]

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References

[1] European Medicines Agency (EMA). Product information for darolutamide (Rezenopy). EMA. https://www.ema.europa.eu/