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

Suppliers for the Pharmaceutical Drug: Tromethamine

Last updated: July 29, 2025

Introduction

Tromethamine, commercially known as Tris or Tris(hydroxymethyl)aminomethane, is a widely used pharmaceutical compound primarily employed as a buffering agent in medical and laboratory applications. Its critical role in maintaining pH stability in intravenous solutions, dialysis solutions, and biopharmaceutical formulations underscores the importance of a reliable supply chain. This article provides an in-depth overview of key suppliers, market dynamics, and considerations for stakeholders seeking to source tromethamine efficiently and securely.

Market Overview of Tromethamine

The global demand for tromethamine has grown steadily, driven by its application in emergency medicine, anesthesia, dialysis, and as a stabilizer in pharmaceutical formulations. The compound’s stability, ease of manufacturing, and regulatory acceptance have sustained its supply chain. Major manufacturing regions include China, India, Europe, and North America, with several companies serving as primary suppliers.

Leading Suppliers of Tromethamine

1. BASF SE

   Profile: As one of the world's largest chemical producers, BASF supplies pharmaceutical excipients, including tromethamine, globally. Its established manufacturing infrastructure ensures consistency in purity, quality, and supply.

   Capabilities: BASF offers high-quality tromethamine conforming to pharmacopeial standards (USP, EP, JP), suitable for use in injectable and oral formulations. They maintain strict quality controls aligned with pharmaceutical industry regulations.

2. FMC Corporation

   Profile: FMC specializes in specialty chemicals with a notable presence in pharmaceutical intermediates including tromethamine. Its facilities in North America and Europe enable a reliable source of GMP-grade tromethamine.

   Capabilities: FMC provides tromethamine with comprehensive documentation supporting regulatory compliance. Its supply chain emphasizes consistency and traceability, critical for pharmaceutical manufacturing.

3. Sancheti Pharmaceuticals

   Profile: An India-based manufacturer, Sancheti Pharmaceuticals has positioned itself as a key regional supplier of pharmaceutical chemicals, including tromethamine.

   Capabilities: Offers high-quality tromethamine with adherence to international standards, competitive pricing, and flexible batch sizes suitable for research and commercial production.

4. Jubiliant Life Sciences

   Profile: Headquartered in India, Jubiliant offers a broad portfolio of pharmaceutical ingredients, including tromethamine, supported by GMP-certified manufacturing facilities.

   Capabilities: Known for scalable production, their tromethamine meets global regulatory standards, and they have an extensive distribution network.

5. Siegfrid Pharma

   Profile: A European supplier specializing in pharmaceutical excipients and chemicals, Siegfrid Pharma provides high-grade tromethamine for injection-grade applications.

   Capabilities: Their strict quality assurance processes fulfill pharmacopeial specifications, and they often cater to the European and North American markets.

Emerging and Regional Suppliers

As the demand for tromethamine continues to grow, emerging suppliers in China, South Korea, and Southeast Asia are expanding their manufacturing capacities. Companies such as Nanjing Pharmaceutical Corporation and Hubei Green Cross Pharmaceutical are increasingly recognized for producing GMP-compliant tromethamine.

Factors Influencing Supplier Selection

• Regulatory Compliance: Suppliers must provide documentation supporting compliance with USP, EP, or JP standards. Validation and certificates of analysis are essential for regulatory submission.

• Quality Assurance: Consistent purity, absence of contaminants, and stability are critical parameters. Suppliers with robust quality management systems and adherence to Good Manufacturing Practices (GMP) are preferred.

• Supply Chain Stability: Lead times, production capacity, and geopolitical stability influence the reliability of supply. Long-term relationships and diversified sourcing help mitigate risks.

• Pricing and Logistics: Competitive pricing, flexible MOQ (Minimum Order Quantity), and efficient logistics are decisive factors, especially for large-scale manufacturers.

Supply Chain Challenges

The pharmaceutical industry faces specific challenges in sourcing tromethamine:

• Regulatory Variability: Different regional standards require thorough due diligence to ensure supplier compliance.

• Supply Disruptions: Geopolitical tensions, raw material shortages, or manufacturing issues can impact availability.

• Quality Variability: Variations in purity levels or manufacturing processes across suppliers necessitate comprehensive qualification processes.

Regulatory and Procurement Recommendations

Stakeholders should conduct supplier qualification audits, review batch records, and verify certification compliance before establishing long-term contracts. Engaging with reputable suppliers who can provide extensive documentation — including stability data, Certificates of Analysis (COA), and manufacturing process validation — lowers regulatory risks.

Conclusion

The supply landscape for tromethamine is characterized by established global players like BASF and FMC, regional manufacturers in Asia, and emerging suppliers eager to expand market share. Strategic sourcing, emphasizing regulatory compliance, quality assurance, and supply stability, is essential to ensure uninterrupted availability. As the pharmaceutical industry continues to evolve, fostering relationships with reliable suppliers remains a business-critical activity.

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Key Takeaways

• Major global suppliers include BASF, FMC, and Jubiliant, offering high-quality, GMP-compliant tromethamine.
• Regional and emerging suppliers, especially in Asia, are expanding their market presence, often providing cost-effective options.
• Due diligence in verifying regulatory compliance and quality standards is imperative for safe procurement.
• Supply chain resilience can be improved through diversified sourcing and strategic partnerships.
• Continuous monitoring of regulatory developments and supplier performance enhances procurement security.

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FAQs

1. What are the primary applications of tromethamine in pharmaceuticals?
Tromethamine is used as a buffering agent in IV fluids, dialysis solutions, and as a stabilizer in various drug formulations to maintain pH integrity.

2. How do I verify the quality of tromethamine from a supplier?
Request Certificates of Analysis, validate compliance with pharmacopeial standards, and consider third-party audits or testing to confirm purity, absence of contaminants, and batch consistency.

3. Are there regulatory hurdles in sourcing tromethamine globally?
Yes. Different regions have distinct standards and documentation requirements. Ensuring supplier compliance with applicable regulatory frameworks (e.g., FDA, EMA, PMDA) mitigates risks.

4. How does geopolitical stability affect tromethamine supply?
Manufacturing disruptions due to geopolitical issues, trade restrictions, or raw material shortages may impact supply. Diversified sourcing and regional manufacturing partnerships mitigate these risks.

5. What factors should guide long-term sourcing strategies for tromethamine?
Prioritize suppliers with proven regulatory compliance, robust quality systems, stable production capacity, and reliable logistics. Building strong partnerships facilitates continuity and compliance.

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References

1. [1] BASF SE, "Pharmaceutical excipients," BASF Product Portfolio, 2022.
2. [2] FMC Corporation, "Pharmaceutical Intermediates," FMC Industry Report, 2021.
3. [3] World Health Organization, "Global Pharmaceutical Supply Chains," WHO Reports, 2020.
4. [4] ICH Q7 Guidelines, "Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients," 2001.
5. [5] U.S. Pharmacopeia, "USP Monograph for Tromethamine," 2022.