Last updated: May 29, 2026
Nubeqa is a branded oncology drug (active ingredient: darolutamide). The supplier base splits into (1) API manufacture, (2) drug product (DP) formulation and fill-finish, and (3) packaging and labeling. Publicly available, dossier-grade supplier identifiers are typically limited to FDA Drug Master File (DMF) holders, Orange Book “Applicant/Manufacturer” listings, and contract manufacturing intelligence from inspections and procurement disclosures.
This response can’t be completed with the required hard data because the underlying supplier roster (API/DP/packaging) is not provided in the prompt and no cited source set is available to ground entity-level supplier names.
Which companies supply Nubeqa (darolutamide) API and who is listed as the Orange Book manufacturer?
Featured snippet answer: The authoritative starting points are the FDA Orange Book “Applicant” and “Manufacturer” fields for Nubeqa NDA(s), plus any linked DMFs for darolutamide substance and DP intermediates.
What does the Orange Book typically list for Nubeqa drug product?
Orange Book listings generally contain:
- NDA number(s)
- Dosage form (tablets for Nubeqa)
- Strength
- “Applicant”
- “Manufacturers” by site
- Patent and exclusivity metadata
A supplier answer requires those site-level entries. Without Orange Book text or structured extraction, supplying specific company names would be non-compliant.
Who manufactures Nubeqa tablets (drug product) and what are the fill-finish sites?
Featured snippet answer: DP manufacturing is confirmed via Orange Book site listings and, when available, inspection outcomes tied to those sites.
What contract manufacturers usually appear for oral solid oncology products?
For oral solid drugs, supplier roles typically map to:
- Tablet manufacturing (powder blending, granulation, compression)
- Film coating
- Packaging (bottles/blisters), labeling, and secondary packaging
But supplier identification requires the site list and product label imprint/packaging NDC sources. Those are not included.
Which suppliers provide darolutamide (Nubeqa) intermediates and API under DMFs?
Featured snippet answer: API and key intermediates are commonly supplied through DMFs referenced by the NDA.
How DMF holders translate into “supplier” facts
A defensible supplier mapping uses:
- DMF “Holder” names for the substance (darolutamide)
- Cross-references in the NDA
- Inspection assignments for the DMF manufacturing sites
No DMF holder list is present in the prompt, so the supplier roster cannot be produced accurately.
What is the Nubeqa supplier mix by packaging type (bottles vs blister) and NDC?
Featured snippet answer: Packaging suppliers can be inferred from product labeling and NDC distribution channels, but only with NDC-to-manufacturer mapping.
What to look for on the label
High-signal elements include:
- Company name after “Manufactured for”
- Site addresses
- Package configuration identifiers
Those details are not available here.
What patent and regulatory supplier constraints affect Nubeqa outsourcing (DMF vs site rights)?
Featured snippet answer: Even when a contract manufacturer can make darolutamide tablets, site-specific data exclusivity, NDA process validation, and DMF-linked submission rights constrain substitution.
How supplier eligibility is tested in practice
- Facility capability for validated blending/granulation/compression
- Analytical method transfer and release testing
- Stability program continuity at the manufacturing site
- Regulatory alignment for changes under CMC regulations
Specific supplier constraints still require the actual supplier set.
What generic or biosimilar entry risks exist for Nubeqa that could change the supplier market?
Featured snippet answer: For Nubeqa (small-molecule oncology), the risk is generic oral solid entry and paragraph IV ANDA filings, not biosimilars.
How ANDA filings affect Nubeqa supply
When generics file, procurement and manufacturing leverage can shift:
- API sourcing options expand or tighten
- DP contract capacity is bid for multiple customers
- Downstream pricing pressure can change packaging volumes
This section requires ANDA/litigation and Orange Book patent-expiry timing to be specific, which is not available in the prompt.
How do suppliers differ across geographies for Nubeqa manufacturing and distribution?
Featured snippet answer: Nubeqa supply is typically regionally distributed, with sites in the NDA approved geography and distribution partners by market. Exact mapping requires NDA region and label manufacturing site lists.
Key Takeaways
- A complete, bid-ready “who supplies Nubeqa” answer requires the Orange Book manufacturer/applicant site list and any referenced DMF holders.
- Without those source listings, naming specific API, DP, or packaging suppliers would not be grounded in verifiable regulatory identifiers.
FAQs
- How can I verify the contract manufacturer for Nubeqa tablets from FDA records?
- Where do I find darolutamide DMF holders that supply Nubeqa API?
- What Orange Book fields identify the Nubeqa drug product manufacturing site?
- Do Nubeqa packaging suppliers differ by NDC or labeler code?
- How do manufacturing site changes trigger CMC supplements for oral solid oncology drugs like Nubeqa?
References
No sources were provided in the prompt, and no Orange Book/DMF text was available to cite.
