Last updated: May 31, 2026
CARDURA (doxazosin) Suppliers: API, Finished Dosage, Contract Manufacturing, and Key Supply-Side Risks
Executive summary: CARDURA is a branded oral alpha-1 blocker (doxazosin) with sourcing that is typically split across (1) doxazosin active pharmaceutical ingredient (API) manufacturers, (2) finished-dose suppliers for CARDURA tablets and related generics, and (3) contract manufacturing organizations (CMOs) that produce tablet strengths under label or private-label arrangements. Specific CARDURA supply contracts are not publicly enumerated in a way that supports a complete, defensible supplier list without relying on non-primary or potentially inaccurate market claims.
No complete and accurate supplier roster can be produced from verifiable public records within the constraints.
Which companies supply CARDURA doxazosin tablets?
Featured answer: A definitive, complete list of companies that supply CARDURA tablets by brand label is not publicly available in a structured, primary source format.
What supply roles exist in CARDURA’s value chain
- API supply: doxazosin mesylate/doxazosin substance manufacturers.
- Formulation and finishing: tablet formulation, blending, granulation (if applicable), compression, coating, and packaging.
- Quality systems: cGMP manufacturing and batch release for NDA/brand-labeled distribution.
What primary sources typically disclose for branded products
- FDA drug product labeling and change notifications: generally do not name all external suppliers.
- Manufacturing sites in FDA approvals/CMC supplements: site-level disclosure may exist but does not map 1:1 to “suppliers.”
- Orange Book listing: identifies applicant/holder and approved products, not the full external supplier map.
Who makes the CARDURA doxazosin API (active ingredient)?
Featured answer: The doxazosin API supply base is broader than the CARDURA brand label holder, with multiple global API manufacturers serving the generic doxazosin market. A complete “CARDURA-specific” API supplier list is not verifiable from primary sources in a way that supports a full procurement-style roster.
Why API sourcing is hard to tie to the brand
- Brand and generic tablets often share the same API suppliers.
- A brand may shift API suppliers across lifecycle for cost, capacity, or regulatory reasons.
- External API is often purchased through distributor networks not disclosed on labels.
Which contract manufacturing organizations produce CARDURA tablets?
Featured answer: Contract manufacturing sites are not consistently disclosed as “CMA/CMO” suppliers in public, primary records for CARDURA as a brand.
How to interpret manufacturing disclosures that do exist
- FDA approval documents may list drug product manufacturing sites and responsible parties.
- Those entries can be read as “manufacturing locations used in approval,” not necessarily “the current production-day supplier.”
Does the CARDURA supply chain differ by strength and dosage form?
Featured answer: For oral tablets, strength-to-strength manufacturing may involve different compression lines, packaging configurations, and sometimes different sites, depending on approval strategy and technical transfer history.
Strength-specific considerations that affect suppliers
- Tablet formulation and coating system
- Packaging configuration (bottle size, blister formats if used)
- Stability and hold-time parameters tied to manufacturing site equipment and process controls
How do generics of doxazosin compete on supply, and what supplier overlap exists?
Featured answer: Generic doxazosin tablet supply networks typically overlap with the broader doxazosin API and tablet-filling supplier base, so generic manufacturers and CMOs are often the same commercial production nodes used across brands.
Where overlap usually shows up
- Common API sources used by multiple ANDA holders
- Same CMO sites producing tablets for multiple labelers
What Orange Book status does CARDURA have, and how does it affect sourcing?
Featured answer: Orange Book status impacts exclusivity and whether ANDA approvals can enter, but it does not directly enumerate “suppliers.” For CARDURA, the commercial market is heavily genericized, which generally means multiple supplier pathways exist for doxazosin tablets.
Procurement implication
- When multiple generic sources exist, CARDURA-specific supply contracts become less central than the availability of doxazosin API and tablet manufacturing capacity.
What patent estate issues matter for CARDURA supply or generic manufacturing?
Featured answer: Patent and method/formulation coverage can affect generic manufacturing and entry design, but they do not by themselves restrict who can manufacture if the product is not infringing.
Supply-side legal constraints that can arise
- Formulation patents: excipient system, coating, or dissolution profile
- Method-of-use patents: less relevant for “manufacture of the tablet,” more for labeling and carve-outs
- Process patents: manufacturing steps and impurities can require process design changes
What FDA regulatory milestones affect CARDURA supplier qualification?
Featured answer: Supplier qualification is governed by cGMP compliance, NDA/ANDA manufacturing site approvals, and ongoing inspections, not by brand label ownership alone.
Key operational control points
- cGMP inspection outcomes for the manufacturing site(s)
- Batch record compliance and validation documentation
- Stability program maintenance
Which suppliers are safest for continuity of supply if CARDURA demand is high?
Featured answer: In practice, continuity is driven by API redundancy and CMO capacity for tablet filling and packaging, with suppliers that have demonstrated regulatory compliance histories.
Risk areas
- Single-source API dependencies
- Site-specific equipment or process bottlenecks
- Packaging component constraints (bottles, seals, blister foils)
Key Takeaways
- CARDURA’s supply chain is composed of API suppliers, tablet manufacturers, and packaging/release participants, but a complete “CARDURA supplier list” is not verifiable from primary public sources in a way that supports a procurement-grade answer.
- For doxazosin tablets, supply networks are typically shared across the branded and generic market, making the doxazosin API and oral-tablet CMO base more relevant than “CARDURA-specific” supplier names.
- Patent status affects labeling and design choices, not the ability to manufacture unless a specific patent is implicated in the manufacturing or formulation.
FAQs
- What does the CARDURA label disclose about manufacturing sites?
- How can I identify doxazosin API suppliers from FDA or regulatory filings?
- Do CARDURA and generic doxazosin tablets use the same manufacturing locations?
- What regulatory findings most commonly disrupt doxazosin tablet supply?
- How does packaging type (bottle vs blister) change the supplier and CMO setup for doxazosin tablets?
References
- U.S. Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations.
- FDA. Approved Drug Products and Related Documents (Drugs@FDA).
- FDA. Guidance for Industry: cGMP for Phase 1 Investigational Drugs (and related cGMP guidance for manufacturing quality systems).
