Suppliers and packagers for generic pharmaceutical drug: tromethamine

tromethamine

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Hospira	THAM	tromethamine	SOLUTION;INJECTION	013025	NDA	Hospira, Inc.	0409-1593-04	6 BOTTLE, GLASS in 1 CASE (0409-1593-04) / 500 mL in 1 BOTTLE, GLASS (0409-1593-14)	2020-06-24
B Braun Medical	TROMETHAMINE	tromethamine	SOLUTION;INJECTION	211558	ANDA	B. Braun Medical Inc.	0264-8031-10	24 BAG in 1 CASE (0264-8031-10) / 500 mL in 1 BAG	2025-08-27
Milla Pharms	TROMETHAMINE	tromethamine	SOLUTION;INJECTION	213116	ANDA	MILLA PHARMACEUTICALS INC.	71357-001-01	6 BOTTLE, GLASS in 1 CASE (71357-001-01) / 500 mL in 1 BOTTLE, GLASS (71357-001-06)	2024-12-31

TROMETHAMINE Suppliers: Global Commercial Source Set for Drug-Grade Procurement

Last updated: April 23, 2026

Who supplies tromethamine for pharmaceutical use?

Tromethamine (also known as Tris base; CAS 77-86-1; IUPAC: 2-amino-2-(hydroxymethyl)propane-1,3-diol) is sold by a broad supplier set spanning API manufacturers, chemical specialty houses, and contract producers that market “pharmaceutical grade” or “USP/EP grade” material.

Supplier set (commercially active brands and manufacturers)

Supplier	Commonly listed product form(s)	Typical market positioning	Notes for procurement due diligence
BASF	Tromethamine / Tris base	Chemical specialty	Large-scale supplier; commonly supports downstream pharma and lab markets.
Merck (MilliporeSigma)	Tromethamine (Tris base)	Specialty chemical	Broad catalog coverage for Tris reagents and pharma/life-science grades.
Thermo Fisher Scientific (Gibco/PPD brands vary by listing)	Tromethamine solutions and solids	Life-science and lab-grade	Some listings include buffers and related grades used in injectable formulation support.
Fisher Scientific / VWR (brands via distribution networks)	Tromethamine (Tris base)	Distributor	Distributor can be a buying channel; ensure the distributor label matches API excipient quality requirements.
Jungbunzlauer	Tromethamine	Specialty chemicals	Supplier set is common for pharma-focused intermediates and functional ingredients.
ACM (Asian Chemical Markets) / local pharma-chemical houses	Tromethamine	Regional chemical supplier	Regional suppliers are common for excipient sourcing; validate documentation (CoA, DMF/CEP when applicable).
TCI Chemicals	Tromethamine (Tris base)	Specialty chemical	Frequently supplies research and process grades; request pharma-grade documentation for intended use.
Macklin / Aladdin / similar chemical catalog vendors	Tromethamine	Chemical catalog suppliers	Often lab-to-industrial catalogs; verify USP/EP alignment and quality agreements for pharma.
Wuhan/China-based fine chemical manufacturers (catalog and tender suppliers)	Tromethamine (solid)	API/excipient supply	Commonly compete on price and lead time; require audit-ready quality packages for pharma use.

Operational guidance for buyers: For “pharmaceutical use,” tromethamine is typically handled under excipient or buffer/tonicity agent supply expectations. The buying package usually needs CoA, specification sheet, impurity profile, residual solvents, microbial limits (if applicable), and traceability. When tromethamine is used in parenteral contexts, buyers should require supplier documentation consistent with injectable-grade controls.

Which suppliers are most relevant for pharma-grade dossiers?

Supplier selection tends to cluster around companies with established compliance and documentation capability. The practical differentiator is not the existence of a tromethamine SKU, but the ability to provide a pharma-grade dossier package.

Pharma-dossier readiness screening checklist (what to match to your procurement)

• Quality documentation: batch CoA, specification, impurity profile, and control strategy (not just “grade label”).
• Regulatory support: CEP where applicable, DMF/ASMF references when applicable to your jurisdiction.
• GxP alignment: manufacturing site qualification, GMP status, and change notification terms.
• Analytical transparency: method references for assay, related substances, water content, and key residuals depending on form.

What commercial product specs are commonly offered for tromethamine?

Commercial listings for tromethamine typically cover solid and aqueous forms, with different packaging and specs.

Common product forms in the market

• Tromethamine (solid; Tris base): used to prepare buffers and formulations.
• Aqueous tromethamine solutions: used for pH adjustment in formulation support and scale-up.
• Tromethamine hydrochloride (separate substance): not the same as tromethamine; buyers must ensure correct identity because the salts have different regulatory and formulation behavior.

Typical spec attributes buyers request

• Assay: usually in the high-purity range for pharmaceutical excipients.
• Related substances: tight limits on known impurities.
• Water content: if controlled as part of excipient spec.
• Residual solvents: if produced or processed with solvents.
• Microbial limits: often required for non-sterile pharma excipients and may be tightened for sterile manufacturing supply chains.

How should buyers structure supplier qualification for tromethamine?

A practical sourcing strategy is to qualify two primary suppliers and keep one backup distributor channel for continuity of supply.

Supplier qualification strategy (typical for excipient procurement)

1. Primary supplier A (direct manufacturer or pharma-leaning specialty house)
   • Focus: documentation depth and reliable batch-to-batch control.
2. Primary supplier B (direct manufacturer or established specialty chemicals supplier)
   • Focus: supply redundancy and comparable impurity control.
3. Secondary channel (authorized distributor)
   • Focus: short lead times and packaging flexibility, with full traceability back to the manufacturer.

Where do procurement risks concentrate?

Tromethamine is usually low-complexity compared to biologics or complex APIs, but procurement risk still concentrates in documentation, impurity control, and shipment continuity.

Risk points

• Grade mismatch: “research grade” or “buffer grade” labels sold alongside pharmaceutical intended use.
• Identity confusion with salts: tromethamine vs tromethamine hydrochloride.
• Batch-to-batch impurity drift: especially for fine chemical grades if production routes differ.
• Supply interruption: depending on whether production is commodity-scale or specialty-lot manufacturing.

What sourcing actions are most defensible for business decisions?

For fast, auditable decisions, buyers typically:

• Lock a spec benchmark first (USP/EP aligned where needed).
• Demand GMP-level CoA and impurity panels.
• Verify manufacturing sites and change control terms.
• Use two-source qualification for supply continuity.

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Key Takeaways

• Tromethamine (Tris base; CAS 77-86-1) is supplied by global chemical specialty houses and large chemical manufacturers with pharma-oriented documentation capabilities.
• The most important procurement filter is not availability, but pharmaceutical-grade documentation and impurity control tied to intended use (excipient/buffer, and whether parenteral is in scope).
• A defensible sourcing model is two qualified direct suppliers plus a distributor backup, with strict identity control to avoid mixing tromethamine with its hydrochloride salt.

FAQs

1. Is tromethamine the same as Tris base?
   Yes. Tromethamine is also known as Tris base.

2. Is tromethamine used as an API or as an excipient?
   Most drug-formulation use is as a buffering agent / excipient (pH adjustment and formulation support), unless a specific product uses it under a defined therapeutic role.

3. How can buyers avoid identity mistakes?
   Confirm CAS number (77-86-1) and name on the CoA and label; do not substitute with tromethamine hydrochloride.

4. What documentation matters most for pharma sourcing?
   CoA per batch, approved specification, impurity/related substances panel, residual solvents (as applicable), and manufacturing/GMP status information.

5. What is the fastest credible sourcing approach?
   Qualify two direct suppliers that can provide pharma-grade documentation packages, and keep an authorized distributor as a continuity backup.

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References

[1] Merck. “Tris (Tromethamine) (CAS 77-86-1) Product Information.” Merck KGaA.
[2] BASF. “Tromethamine (Tris base) Product Information.” BASF SE.
[3] Thermo Fisher Scientific. “Tromethamine and Related Buffer Components (Product Listings).” Thermo Fisher Scientific Inc.
[4] TCI Chemicals. “Tromethamine (Tris base) (CAS 77-86-1) Product Information.” TCI.
[5] Jungbunzlauer. “Tromethamine (Product Information and Supply Capabilities).” Jungbunzlauer.