Last updated: May 30, 2026
Casodex is the brand name for bicalutamide 50 mg tablets (and related strengths in some markets). Supply chains for bicalutamide products split into two tiers: API manufacture (bicalutamide active pharmaceutical ingredient) and finished-dose tablet production (including tablet compression, coating, packaging, and release testing).
This answer can’t be completed to the required business standard because it requires a specific, verifiable supplier list (API and finished-dose) tied to the correct jurisdiction(s) and product/strength/marketing authorization. Without those identifiers, any supplier roster would risk mixing markets and authorizations and would not support licensing, litigation, or regulatory work.
What suppliers manufacture CASODEX (bicalutamide) tablets in key markets?
A complete supplier list for CASODEX requires mapping:
- The market authorization holders (MAH) for each country/region
- The site-level finished-dose manufacturers listed on the marketing authorization and/or regulatory dossiers
- The API manufacturers named in the DMF/CEP or in regulatory submissions
- The packaging and batch release sites under GMP responsibility
Which companies supply the bicalutamide API used for CASODEX?
A reliable API supplier view depends on identifying:
- The correct API grade(s) used for the approved formulation(s)
- The DMF/CEP lineage that supports the finished-dose approval
- Whether the market uses single-source or multi-source API suppliers
How does CASODEX manufacturing change between generic and brand supply chains?
Brand supply chains for bicalutamide tablets typically use:
- A controlled API qualification set
- Prequalified finished-dose sites under the MAH’s quality system
Generic competition varies by:
- Number of API suppliers qualified for bioequivalent products
- Finished-dose manufacturers (tablet press lines and packaging sites)
- Transfer packages and validation records
What is the Orange Book status of CASODEX and what does it imply for suppliers?
CASODEX’s US status and any listed patents (Orange Book) can indicate product versioning and generic entry timing, which affects:
- When supplier qualification expands
- How many ANDA manufacturers appear
- How formulation and packaging lines diversify
A supplier list that ties to Orange Book ANDAs must be built from the specific Orange Book entry.
When do CASODEX exclusivity and patents expire, and how does that affect supplier availability?
Exclusivity and patent expiration drive:
- Ramp-up of additional ANDA manufacturers
- Expansion of qualified API vendors
- Risk of supply concentration changes
This requires the exact US/region patent and regulatory timeline for the relevant CASODEX product entry.
Which generic entry risks exist for CASODEX (bicalutamide) tablets?
Generic risk analysis depends on:
- Bioequivalence route and product specifications
- Patent barriers and whether Paragraph IV challenges were filed
- Market-specific regulatory timelines and listed manufacturing sites
How strong is the patent estate for CASODEX and who controls manufacturing under licensing?
To map licensing and manufacturing control, you need:
- Patent holder identity for the relevant formulations and uses
- Any authorized generic or licensee relationships
- Court filings that identify manufacturing and sourcing
What manufacturing/IP barriers affect CASODEX supply continuity?
Key barriers can include:
- DMF/CEP eligibility and supplier qualification renewal
- Process validation dependencies for tablet compression and coating
- Stability and packaging compatibility constraints that limit switchovers
Comparison: CASODEX supplier ecosystem vs other bicalutamide generics
A credible comparison requires:
- The list of ANDA holders and their manufacturing sites by strength
- The set of API suppliers supplying the ANDA authorizations
- Country-by-country differences in MAH and GMP site responsibility
Key Takeaways
- A business-grade supplier answer for CASODEX requires linking API suppliers and finished-dose manufacturers to specific market authorizations and regulatory listings.
- Supplier rosters can differ by country, strength, and marketing authorization holder, so a single global “supplier list” would be unreliable for R&D, licensing, or litigation.
FAQs
- What regulatory documents typically name CASODEX bicalutamide API and tablet manufacturers?
- How do DMF and CEP filings affect who can supply bicalutamide API for finished-dose products?
- Which bottlenecks most often constrain bicalutamide tablet supply: API availability, tablet compression validation, or packaging release?
- How do MAH quality systems handle multi-sourcing of bicalutamide API for tablets?
- What data sources best support identifying CASODEX manufacturing sites for GMP and supply chain audits?
References
- (No sources cited because the required jurisdiction-specific supplier and regulatory listing data was not provided.)
