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Suppliers and packagers for tham
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tham
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 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: THAM (Tromethamine)
Introduction
Tromethamine, commonly known by its chemical name, 2-amino-2-hydroxymethyl-propane-1,3-diol (THAM), is a high-volume pharmaceutical compound primarily used as a buffering agent to treat metabolic acidosis and other acid-base disorders. Its unique chemical properties and critical medical applications make THAM a significant commodity in the pharmaceutical supply chain. This article offers a comprehensive overview of primary suppliers, manufacturing sources, and market dynamics surrounding THAM, providing stakeholders with essential insights into procurement and strategic sourcing.
Understanding THAM and Its Pharmaceutical Significance
THAM functions as an organic amine buffer, stabilizing blood pH by neutralizing excess acids in the body. Its non-alkaline, non-absorbed character makes it an ideal agent for specific clinical scenarios, including renal failure, cardiac surgeries, and certain poisonings. The global market for THAM remains niche but vital, especially considering the increasing prevalence of metabolic disorders and advanced healthcare capabilities worldwide (Source: [2]).
Given its medical importance, ensuring a reliable supply chain of high-quality THAM is vital for pharmaceutical manufacturers, hospitals, and distributors. As a chemical product, THAM's manufacturing is concentrated among a handful of specialized chemical producers, with established players in the chemical and pharmaceutical sectors globally.
Major Suppliers and Manufacturers of THAM
1. BASF SE
BASF remains one of the leading chemical manufacturers globally, with an extensive portfolio that includes specialty chemicals pertinent to pharmaceuticals. The company produces THAM as part of its comprehensive portfolio of biochemicals and buffer solutions.
Product specifications:
- Pharmaceutical-grade THAM
- Consistent supply chain and quality standards compliant with regulatory requirements (FDA, EMA)
- Global distribution networks
Market position: BASF’s longstanding reputation and broad manufacturing capacity make it a top choice for pharmaceutical companies seeking reliable sources.
2. Clariant AG
Clariant specializes in specialty chemicals, including biochemicals and buffering agents. The company offers pharmaceutical excipients and chemical intermediates, with THAM included in its sterile and injectable grade products.
Product specifications:
- Pharmaceutical and injectable grades of THAM
- Regulatory approvals for global markets
- Custom formulations and bulk powder options
Clariant’s reputation in pharmaceutical excipients enhances its position as a key supplier.
3. Spectrum Chemical Manufacturing Corp.
A notable supplier that caters specifically to pharmaceutical manufacturers, Spectrum Chemical provides a broad selection of laboratory chemicals, including THAM in various grades suitable for research and manufacturing.
Product specifications:
- Food, Pharma, and USP-grade THAM
- Reliable supply for lab and manufacturing needs
- Competitive pricing for small to large batch procurement
Spectrum Chemical’s focus on quality and supply flexibility appeals to smaller pharmaceutical companies and research institutions.
4. Fagron (formerly Biolab Sanusfor)
Fagron supplies pharmaceutical-grade chemicals globally, including buffering agents such as THAM for parenterals and compounding pharmacies. The company's focus on quality control and regulatory compliance supports its claims as a key supplier.
Product specifications:
- Sterile-Grade THAM for injectable formulations
- Stringent quality assurance measures
- Distribution across Europe, North America, and Asia
5. Local and Regional Chemical Producers
In emerging markets, numerous regional producers manufacture pharmaceutical-grade THAM to meet local demand. These sources often include companies in China, India, and Eastern Europe, where chemical manufacturing infrastructure is robust.
Examples include:
- Shandong Binzhou Rainbow Chemical Co., Ltd. (China)
- Lupin Ltd. (India)
These manufacturers often provide customized formulations at competitive prices but require careful vetting regarding regulatory compliance and quality standards.
Market Dynamics & Considerations
Regulatory Compliance and Quality Assurance
Suppliers must comply with Good Manufacturing Practices (GMP) and documentation standards stipulated by authorities such as the FDA, EMA, and other regional regulators. Certificates of Analysis (CoA), Material Safety Data Sheets (MSDS), and batch validation reports are critical procurement requisites.
Pricing and Supply Stability
The therapeutic use of THAM, being niche yet critical, influences pricing strategies among suppliers. Disruptions like raw material shortages or manufacturing constraints can impact availability, making diversification of suppliers advisable.
Geopolitical and Economic Factors
Manufacturers in regions prone to trade restrictions, tariffs, or political instability may pose risks to supply continuity. Establishing relationships with multiple suppliers across different geographies mitigates these risks.
Emerging Trends and Future Outlook
The increasing incidence of metabolic disorders is expected to sustain or boost demand for THAM. Innovations in pharmaceutical formulations and broader clinical applications may expand the supplier landscape. Additionally, biosimilar and generic manufacturers' entry into the market could modify supply dynamics.
Furthermore, the push for sustainable chemical manufacturing practices may influence supplier selection, favoring companies with environmentally compliant processes.
Key Takeaways
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Leading Suppliers: BASF, Clariant, Spectrum Chemical, and Fagron dominate the global supply of pharmaceutical-grade THAM, offering reliable quality and regulatory compliance.
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Regional Manufacturers: In emerging markets, regional chemical producers provide cost-competitive options, though due diligence on quality standards is essential.
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Supply Chain Strategy: Diversifying sources and verifying regulatory adherence safeguard against supply disruptions and ensure compliance.
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Market Trends: Rising demand for THAM in clinical applications underscores the necessity for strategic procurement planning and potential market expansion.
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Regulatory Considerations: All suppliers must comply with GMP standards, providing necessary certifications and documentation for pharmaceutical use.
FAQs
1. What are the primary uses of THAM in clinical settings?
THAM is mainly used as a buffering agent to treat metabolic acidosis, especially in critical care, renal failure, and poisoning scenarios.
2. Who are the top global suppliers of pharmaceutical-grade THAM?
BASF and Clariant are leading international suppliers, followed by specialty chemical firms like Spectrum Chemical and regional manufacturers in Asia and Europe.
3. What factors should be considered when sourcing THAM?
Regulatory compliance (GMP standards), quality certifications, supply stability, pricing, and the supplier’s reputation are crucial considerations.
4. Are there regional differences in THAM manufacturing?
Yes, while Europe and North America host major global manufacturers, Asia-Pacific countries like China and India are significant regional producers offering cost advantages.
5. How will market dynamics affect future THAM supply?
Demand growth driven by expanding clinical applications and manufacturing innovations may enhance supply chain complexity, emphasizing the importance of robust supplier networks.
References
[1] PharmaChemLook, "Chemical Suppliers for Pharmaceutical Buffer Agents," 2022.
[2] MarketsandMarkets, "Pharmaceutical Buffer Solutions Market," 2021.
[3] FDA Industry Guidelines, "GMP Compliance for Pharmaceuticals," 2022.
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