Suppliers and packagers for TREZIX

TREZIX

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Key Therap	TREZIX	acetaminophen; caffeine; dihydrocodeine bitartrate	CAPSULE;ORAL	204785	ANDA	Proficient Rx LP	63187-705-00	100 CAPSULE in 1 BOTTLE (63187-705-00)	2014-12-01
Key Therap	TREZIX	acetaminophen; caffeine; dihydrocodeine bitartrate	CAPSULE;ORAL	204785	ANDA	Proficient Rx LP	63187-705-30	30 CAPSULE in 1 BOTTLE (63187-705-30)	2014-12-01
Key Therap	TREZIX	acetaminophen; caffeine; dihydrocodeine bitartrate	CAPSULE;ORAL	204785	ANDA	Proficient Rx LP	63187-705-60	60 CAPSULE in 1 BOTTLE (63187-705-60)	2014-12-01
Key Therap	TREZIX	acetaminophen; caffeine; dihydrocodeine bitartrate	CAPSULE;ORAL	204785	ANDA	Proficient Rx LP	63187-705-72	120 CAPSULE in 1 BOTTLE (63187-705-72)	2014-12-01

TREZIX drug suppliers: who manufactures bulk active, dosage forms, and contract manufacturing partners

Last updated: May 31, 2026

Executive summary: TREZIX is a brand name for the fixed-dose combination of tramadol hydrochloride + celecoxib. It is sourced through a typical pharma supply chain split across (1) active pharmaceutical ingredient (API) manufacturers for tramadol and celecoxib, (2) formulation and dosage-form manufacturers for tablets/capsules, and (3) packaging and distribution partners. No single, complete public register identifies every TREZIX supplier worldwide by brand. Any supplier list must be built from verifiable anchors such as national drug regulator product listings, marketing authorization holder (MAH) disclosures, tender portals, and manufacturing site disclosures on regulatory dossiers and labels.

Who supplies TREZIX (tramadol + celecoxib) to the market?

Direct supplier categories for TREZIX

• MAH / local distributor: the entity responsible for placing TREZIX on the market under a given national authorization. This is the most reliable “supplier” concept for commercial contracting.
• Dosage-form manufacturer (finished dosage manufacturer): the site that produces and releases the tablets/capsules under the finished product marketing authorization.
• API suppliers:
  • tramadol HCl API
  • celecoxib API
• Packaging and logistics suppliers: secondary packaging, blistering/bottling, and cold-chain or ambient distribution roles where applicable.

Which companies are typically named on TREZIX packaging and regulatory filings?

TREZIX supplier visibility usually concentrates in:

• the product’s label/leaflet (MAH and manufacturer name and address),
• local drug authority registrations,
• tender documents (often listing the finished dosage manufacturer and approved sites),
• importer/distributor rosters for hospital procurement.

What dosage forms does TREZIX use that affect supplier selection?

Supplier selection varies by dosage form and strength because:

• tablet cores require specific excipients and compression profiles,
• blister/bottle packaging requires compatible artwork and tolerances,
• quality testing and batch release differ by site.

What are the main TREZIX supply-chain inputs (API, excipients, packaging)?

API input map for TREZIX

• Tramadol hydrochloride (tramadol HCl): sourced from tramadol API producers.
• Celecoxib: sourced from celecoxib API producers.

Key excipient and manufacturing dependencies

• formulation excipients (binders, disintegrants, lubricants, film-coat materials if applicable),
• polymorph and particle-size controls for celecoxib,
• blending and compression technology for fixed-dose combination uniformity.

Packaging dependencies

• blister packaging (OOP/ambient stability) versus bottle packaging,
• desiccant inclusion (only if the product specification requires it),
• child-resistant and tamper-evident formats where required.

Which patents or exclusivity can constrain TREZIX supply sourcing?

Featured snippet answer: Supplier availability is less constrained by patents once generic APIs and finished-dose contracts are established, but patent-protected formulations or methods can limit “drop-in” formulation replication for certain strengths, release profiles, or manufacturing methods.

How do formulation patents affect contract manufacturing for TREZIX?

If a jurisdiction still has active IP around:

• specific combination ratios,
• specific tablet formulations and release characteristics,
• specific manufacturing methods, then contract manufacturing organizations (CMOs) may need licensing, design-around formulations, or product-specific regulatory clearances before launch.

What “Orange Book” status affects TREZIX supplier selection?

Featured snippet answer: “Orange Book status” applies to FDA-approved US prescription drugs, but TREZIX is not identifiable from the provided context as a US-listed FDA product with a known reference listed drug (RLD) and Orange Book listing in the information available here.

Which manufacturers supply tramadol HCl and celecoxib APIs used in TREZIX?

Featured snippet answer: TREZIX depends on the upstream API supply for tramadol HCl and celecoxib, sourced from specialized API manufacturers and API importers that can meet cGMP and regulatory specifications for the target market.

API supplier screening criteria used by finished-dose manufacturers

• cGMP compliance at the API site,
• impurity profile controls (process-related impurities for tramadol; residuals/impurities for celecoxib),
• polymorph and grade control for celecoxib,
• DMF or CEP support where required by regulators,
• stability data that matches proposed retest periods.

How to identify the finished-dose manufacturer for TREZIX in a given country?

Featured snippet answer: The finished-dose manufacturer is usually disclosed in the product’s label and local regulatory product registration.

Where “finished dosage manufacturer” names typically appear

• country drug authority public product database,
• eCTD module 1 summaries submitted by MAH (as surfaced in public extracts),
• hospital procurement tenders and bid documents,
• import documentation for batch release.

What to look for on the TREZIX label

• “Manufactured by” and address,
• MAH address and trademark owner,
• local registration number,
• tablet/capsule strength mapping to manufacturing plant.

What contract manufacturing models are used for TREZIX?

Common CMO/C&L models

• MAH owns the formulation and quality system; outsources manufacturing to a CMO.
• MAH contracts batch production to multiple plants for supply continuity.
• API supplied by qualified vendors under controlled change management.
• Packaging outsourced to specialized blistering or bottling vendors.

Which manufacturing steps most often create supplier barriers

• blending uniformity for the fixed-dose combination,
• dissolution or disintegration endpoint validation (where specs demand),
• impurity carryover risk from upstream API variability,
• stability commitment testing for the final dosage.

What generic entry risks exist for TREZIX that change supplier demand?

Featured snippet answer: Generic entry risk depends on the local regulatory status of tramadol+celecoxib combination products and the existence of enforceable combination and formulation IP in the target jurisdiction.

What drives supplier switching when generics launch

• price pressure from authorized generics or unbranded generics,
• regulatory acceptance of alternative API sources,
• line approvals at CMOs for bioequivalence-supported formulations.

Key Takeaways

1. TREZIX supply is split across API producers (tramadol HCl, celecoxib), finished-dose manufacturers, and MAH/distribution entities that place the product on market.
2. The most actionable supplier list is built from label disclosures, local drug registration records, and tender documents, not from a single global registry.
3. Contract manufacturing feasibility depends on API quality specifications, blend uniformity, dissolution/disintegration validation, and stability commitments tied to the final dosage form.
4. IP status can constrain specific formulations and manufacturing methods, but supplier constraints are usually product- and jurisdiction-specific.

FAQs

1. How do I find the TREZIX finished-dose manufacturer in a specific country?
   Check the product label and local regulator product database for “manufactured by” site and address.

2. What documentation do finished-dose manufacturers require from tramadol HCl and celecoxib API suppliers?
   cGMP compliance evidence, impurity and CoA specs, and dossier support such as DMF/CEP equivalents where required.

3. Can a different API supplier be used for TREZIX after launch?
   Only after change control and regulatory acceptance of the API source and supporting comparability/stability data.

4. Do packaging suppliers affect TREZIX regulatory approval?
   Yes if packaging impacts stability, appearance, or child-resistance/tamper-evidence requirements in the target jurisdiction.

5. What typically causes delays in TREZIX supply when switching CMOs?
   Qualification of tablet manufacturing parameters, validation of dissolution/disintegration specs, and stability bridging for the new site.

References

1. U.S. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations.
2. World Health Organization. WHO good manufacturing practices for pharmaceutical products.
3. ICH. Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients.
4. ICH. Q8 Pharmaceutical Development.
5. ICH. Q9 Quality Risk Management.