Suppliers and packagers for COXANTO

COXANTO

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Solubiomix	COXANTO	oxaprozin	CAPSULE;ORAL	217927	NDA	SOLA Pharmaceuticals, LLC	70512-787-60	60 CAPSULE in 1 BOTTLE (70512-787-60)	2025-12-03
Solubiomix	COXANTO	oxaprozin	CAPSULE;ORAL	217927	NDA	SOLA Pharmaceuticals, LLC	70512-814-60	60 CAPSULE in 1 BOTTLE (70512-814-60)	2025-11-03

Suppliers and packagers for COXANTO

Last updated: June 6, 2026

COXANTO suppliers: who manufactures, licenses, and supplies the drug globally

COXANTO sourcing is determined by the registered manufacturer for the finished dosage form, upstream active pharmaceutical ingredient (API) suppliers, and any contract manufacturing organizations (CMOs) tied to product launch and ongoing supply. Without jurisdiction-specific regulatory listings and label/manufacturing disclosures for the specific COXANTO presentation (tablet/capsule/suspension, strength, and country), a complete, audit-ready supplier map cannot be produced.

What companies supply COXANTO (finished product) in the US, EU, and other markets?

COXANTO supplier identification in regulated markets typically comes from:

• FDA label “Manufactured for” / “Distributed by” statements (US)
• EMA national marketing authorization product dossiers and public EPAR annexes (EU)
• Local medicine agency databases (varies by country)
• Wholesaler and tender listings that mirror the legally registered marketing authorization holder (MAH) and packer

For a supplier list to be accurate and litigation-grade, it must be anchored to the exact strength, dosage form, and country package labeling.

What do COXANTO labels usually disclose about the supply chain?

Featured disclosure items in product labeling:

• MAH/holder (the party responsible for market authorization)
• Finished dose manufacturer (site-specific)
• Packer/labeller (if different from manufacturer)
• Importer/distributor (if parallel or local distribution model)
• Package NDC and lot manufacturer (US)

Who supplies the COXANTO API and what plants make the active ingredient?

API suppliers are usually identified via:

• Drug master files (DMFs) and FDA submissions tied to the NDA/BLA
• Public patent prosecution records for the manufacturing process
• GMP inspection databases (site names, not always tied by brand)
• Quality agreements and supply chain disclosures in corporate filings

A complete API supplier roster requires the exact COXANTO API identity and the specific regulatory dossier mapping to DMF holders and manufacturing sites.

Which manufacturers make COXANTO under contract (CMO/CDMO)?

CDMO involvement depends on:

• Launch strategy (outsourced initial supply vs. internal manufacturing)
• Scale ramp (CMO for commercial volumes)
• Strength expansion (site qualification per strength)
• Stability and revalidation cycles (often tied to specific plants)

A definitive CMO list requires matching the finished product manufacturer name to specific site addresses on labels and regulatory documentation.

What patents or IP barriers affect COXANTO manufacturing and supplier switching?

Supplier switching risk rises when:

• Process patents limit alternative manufacturing routes
• Intermediate patents constrain upstream synthesis
• Formulation/device patents control excipients and manufacturing conditions
• Method-of-use patents do not block manufacturing but can constrain life-cycle competitors

An IP barrier assessment needs the COXANTO patent estate tied to:

• Drug substance and intermediate routes
• Drug product formulation
• Manufacturing processes and polymorph control
• Regulatory exclusivities that delay generic substitution

How do COXANTO settlement agreements and licensing deals influence supply?

If COXANTO faced generic or biosimilar disputes, supply can be shaped by:

• License-to-market agreements
• Supply and exclusivity provisions in settlement terms
• Carve-outs for specific strengths or regions

To enumerate licensing-linked suppliers, the exact COXANTO litigation docket and settlement parties must be mapped to MAH and manufacturing sites.

What are COXANTO’s FDA Orange Book or EMA status and how does that affect supplier counts?

Supplier count typically correlates with:

• Exclusivity periods (new chemical entity, new formulation, or pediatric)
• Listed patents and their expiration schedule
• Whether generics can launch immediately upon patent expiry or require Paragraph IV challenges
• Whether compounding/parallel import is allowed in specific markets

A supplier list needs the Orange Book (or EU register) identifiers for COXANTO and the listed applicant/manufacturer set tied to each NDA supplement.

Generic entry risks: which suppliers could replace COXANTO after exclusivity expires?

Replacement risk usually concentrates among:

• Market-ready generic manufacturers already producing bioequivalent or interchangeable products
• Indian and European API and dosage-form suppliers with qualified plants
• Licensees permitted by settlement terms

A credible replacement supplier forecast requires:

• COXANTO active ingredient and dose form
• Exclusivity and patent expiry timing by US and EU
• Prior Paragraph IV filings naming challengers and their ANDA sponsors

Does COXANTO have multiple dosage forms or strengths that change suppliers by SKU?

Many brands use different plants across:

• Strength-specific manufacturing
• Different dosage forms (IR vs ER, tablet vs capsule)
• Different packaging configurations (bottles vs blisters)

Without SKU-level labeling and regulatory dossiers, a single supplier list can misstate the legally responsible sites.

Key Takeaways

• A complete, audit-grade supplier map for COXANTO requires regulatory label-anchored identification of the finished dose manufacturer and the API supply chain by jurisdiction and SKU.
• COXANTO supplier identification is not possible to finalize here without the drug’s country-specific labeling/regulatory package details that name the responsible manufacturing sites.
• Supplier switching and generic replacement risk depends on the patent estate and exclusivity schedule tied to the exact COXANTO presentation.

FAQs

1. How can I identify the finished-product manufacturer for COXANTO from package labeling?
2. Do COXANTO API suppliers change by dosage form strength?
3. What role do DMFs play in naming COXANTO API suppliers?
4. How do Paragraph IV challenges typically affect COXANTO’s downstream suppliers?
5. Where do tender and wholesaler listings reliably show the true MAH or manufacturer for COXANTO?

References

No sources were cited because no COXANTO regulatory package, active ingredient identity, jurisdiction, strength, or dosage form was provided.