Last updated: May 26, 2026
ERLEADA (apalutamide) suppliers: API, contract manufacturers, and key upstream sources
ERLEADA’s supply chain is anchored by (1) apalutamide active pharmaceutical ingredient (API) manufacture, (2) finished-dose tablet production for apalutamide tablets, and (3) packaging and release activities under manufacturer and distributor labels used for global markets.
Because supplier identification depends on Orange Book labeling, FDA drug application manufacturing sites, and vendor disclosures in filings and regulatory databases, providing a complete, accurate supplier roster is not possible from the information available in this request.
Who supplies ERLEADA apalutamide tablets (finished-dose manufacturers)?
Answer: Finished-dose tablet manufacturing and pack/label operations for ERLEADA are determined by the specific NDA labeling and country distribution chain.
What manufacturers are listed for ERLEADA tablets on FDA labeling and submissions?
Answer: These are site-specific and must be pulled from ERLEADA’s FDA labeling or the application’s manufacturing sections (for drug product sites, not API).
Which companies distribute ERLEADA by market?
Answer: Distribution depends on local licensing and wholesale/marketing authorizations and varies by country.
What companies supply apalutamide API for ERLEADA?
Answer: Apalutamide API sourcing is determined by the NDA’s API section (or permitted DMFs/ASMFs) and is not reliably inferable without direct database extraction.
How many apalutamide API suppliers feed ERLEADA?
Answer: Multiple suppliers may qualify under manufacturing supplements or DMFs, but the exact count requires ERLEADA’s disclosed API sources.
Which API suppliers are most exposed to supply disruption risk?
Answer: Risk concentrates where single-site supply is used for commercial lots, but the single-site status must be confirmed from regulatory/CMC documents.
Which Orange Book listings show ERLEADA manufacturers and site-level details?
Answer: Orange Book identifies covered products and may include application and labeler information; it does not reliably enumerate every manufacturing site or every API supplier without cross-referencing labeling and CMC.
What is the Orange Book status of ERLEADA and how does that relate to suppliers?
Answer: Patent/exclusivity status affects entry timing, not directly the supplier list. Supplier status is determined by NDA/CMC labeling and manufacturing authorizations.
What contract manufacturers produce ERLEADA tablets (CMO/CDMO)?
Answer: Tablet production for ERLEADA is handled by the NDA-identified drug product manufacturer(s) and their contract manufacturing network. Accurate CMO/CDMO identification requires the drug product manufacturing site disclosure.
Are there multiple tablet strengths or dosage forms with different suppliers?
Answer: ERLEADA is marketed as apalutamide tablets. Strength-level packaging and release can differ by site and market; confirmed mapping requires drug product labeler/manufacturer extraction.
What packaging and logistics suppliers support ERLEADA (bottles, cartons, labels)?
Answer: Packaging vendors and logistics providers are typically not fully enumerated in public FDA summaries. They are usually disclosed in supply chain documentation used by the marketing authorization holder.
How do packaging suppliers affect lead times and continuity of supply?
Answer: Packaging lead time and component availability can drive shipment delays, but vendor names require supply chain disclosure.
When do ERLEADA supplier qualification changes occur (CMC post-approval)?
Answer: Supplier changes occur via CMC supplements and manufacturing site additions. The timing and scope depend on the variation type (e.g., site transfer vs process change) and are tracked in post-approval change records.
What kinds of changes can shift ERLEADA supplier networks?
Answer: Drug substance site changes, new drug product sites, process parameter changes, and packaging component changes.
How does ERLEADA supplier structure impact generic or biosimilar entry risks?
Answer: Generic entry risk is driven by patent landscape, regulatory pathway, and CMC comparability, not by whether specific suppliers are upstream or downstream.
Does API supplier availability determine generic launch timing for apalutamide?
Answer: It can affect readiness for GMP supply, but launch timing is primarily anchored by exclusivity/patents and regulatory approval.
Key Takeaways
- ERLEADA’s supply chain has three layers: apalutamide API manufacture, finished-dose tablet production, and packaging/labeling/distribution.
- A precise list of supplier companies (API, drug product CMOs/CDMOs, packaging vendors) requires extraction from ERLEADA NDA/labeling/manufacturing disclosures, not derivable from the prompt alone.
- Patent and exclusivity status does not directly identify suppliers; it governs entry timing while supplier qualification is handled via CMC.
FAQs
- Which companies manufacture the apalutamide active ingredient for ERLEADA?
- Who is the listed manufacturer for ERLEADA tablets on FDA labeling?
- Are there different ERLEADA tablet manufacturing sites for different markets?
- What packaging companies supply bottles and cartons for ERLEADA distribution?
- How do manufacturing site changes show up in FDA post-approval supplements for ERLEADA?
References (APA)
- FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration. (Accessed via FDA Orange Book database).
- FDA. Drugs@FDA. U.S. Food and Drug Administration. (Accessed via Drugs@FDA database).
