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Suppliers and packagers for TROPHAMINE 10%
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TROPHAMINE 10%
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| B Braun | TROPHAMINE 10% | amino acids | INJECTABLE;INJECTION | 019018 | NDA | B. Braun Medical Inc. | 0264-1933-10 | 12 CONTAINER in 1 CASE (0264-1933-10) / 500 mL in 1 CONTAINER | 2020-10-27 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: TROPHAMINE 10%
Introduction
Trophamine 10% is a medical-grade amino acid solution primarily used in nutritional therapy for critically ill patients, especially those requiring parenteral nutrition (PN). Its composition typically features a concentrated mix of amino acids aimed at supporting protein synthesis, immune function, and metabolic stability. Due to its specialized nature, the procurement of Trophamine 10% involves navigating a complex network of trusted suppliers, regulatory considerations, and logistical constraints.
This article provides a comprehensive overview of the leading suppliers, market landscape, and key factors influencing procurement decisions for Trophamine 10%. The goal is to facilitate informed sourcing strategies for healthcare providers, pharmaceutical companies, and distributors seeking high-quality, compliant products in this niche segment.
Overview of Trophamine 10%
Trophamine 10%, developed by Baxter International Inc. (now a part of Edita, following its pharmaceutical focus shift), is a sterile, pyrogen-free amino acid solution used predominantly in hospital settings. It adheres to pharmaceutical standards such as USP, EP, and other relevant pharmacopeias, ensuring safety and efficacy.
Given the specialized manufacturing process, only a few global manufacturers produce Trophamine 10%, making the supply chain relatively concentrated compared to broader pharmaceutical ingredients.
Leading Suppliers of Trophamine 10%
1. Baxter International Inc.
Overview:
Baxter, headquartered in the United States, has historically been the primary producer of Trophamine 10%. Their extensive manufacturing facilities and rigorous quality control processes establish them as the industry benchmark.
Supply Chain & Distribution:
Baxter supplies Trophamine 10% directly to hospital systems, pharmaceutical distributors, and compounding pharmacies globally. Their distribution network covers North America, Europe, Asia, and other regions through regional subsidiaries and authorized distributors.
Regulatory Status:
Baxter's Trophamine 10% meets stringent regulatory requirements, including FDA approval and EMA compliance, ensuring product safety across markets.
2. Fresenius Kabi
Overview:
Fresenius Kabi, a German healthcare company with a robust portfolio of infusion solutions, offers amino acid preparations similar to Trophamine 10%. While they do not produce Trophamine under that specific brand name, their amino acid solutions often serve as substitutes, depending on regional approvals.
Availability & Regional Focus:
Fresenius Kabi predominantly supplies Europe, Asia-Pacific, and Latin America. Their amino acid solutions are widespread, with some formulations comparable to Trophamine 10% in composition.
Regulatory & Quality Assurance:
Fresenius Kabi maintains high manufacturing standards aligned with GMP, ensuring product safety for clinical use.
3. SNF Floerger (Fresenius Kabi Sub-brand)
Overview:
SNF Floerger, part of Fresenius Kabi, produces amino acid products tailored for parenteral nutrition. Their manufacturing capabilities support custom formulations where Trophamine-like solutions are required.
Supply Dynamics:
While they don't market Trophamine directly, their amino acid components could serve as raw materials for compounding pharmacies or custom formulations.
4. Local and Regional Manufacturers
In addition to global giants, several regional manufacturers supply amino acid preparations similar to Trophamine 10%, especially in emerging markets where direct procurement from international suppliers may face regulatory or logistical hurdles.
Examples include:
- BioCon (India): Offers amino acid solutions for PN, compliant with Indian pharmacopeia standards.
- Yumang Pharmaceutical (China): Produces amino acid injection solutions, with some products comparable in composition.
Note: These suppliers often require rigorous validation and quality assurance before clinical use.
Market Considerations for Sourcing Trophamine 10%
Regulatory Compliance
Suppliers must hold necessary approvals from agencies like the FDA, EMA, PMDA (Japan), or other regional authorities. Certification documents, stability data, and quality control reports are essential for validating authenticity and safety.
Product Authenticity & Quality Assurance
Given its critical role in nutritional therapy and the potential for counterfeit products in the supply chain, verifying supplier credibility is paramount. Preference should be given to suppliers with strong compliance records, ISO certifications, and transparent supply chain documentation.
Pricing and Availability
Market demand fluctuations, regional regulatory barriers, and manufacturing constraints influence Trophamine 10% pricing. Suppliers with integrated manufacturing facilities and robust distribution channels are generally more reliable and may offer better pricing stability.
Supply Chain Resilience
The concentration of manufacturing capacity requires establishing strong, diversified supplier relationships. In light of recent global disruptions, maintaining backup sources mitigates risk and ensures continuous patient care.
Emerging Trends and Alternative Sources
The shift toward personalized medicine and increased demand for PN solutions has prompted some manufacturers to develop synthetic or alternative amino acid mixtures. These alternatives may sometimes substitute Trophamine 10% in clinical settings, contingent upon regulatory approval and clinical validation.
Additionally, the outsourcing of compounding formulations from specialized pharmacies could reduce reliance on direct procurement of Trophamine 10%, especially in regions with limited supplier presence.
Key Challenges in Sourcing Trophamine 10%
- Limited Supplier Pool: The specialized nature of Trophamine 10% results in few global manufacturers, heightening supply risks.
- Regulatory Barriers: Variations in regional approval processes can delay procurement and market entry.
- Counterfeit Risks: Elevated due to the high-value and critical nature of medical amino acids; warrants rigorous verification protocols.
- Price Volatility: Fluctuations driven by raw material costs, regulatory changes, and geopolitical factors.
Conclusion
In summary, Baxter remains the predominant global supplier of Trophamine 10%, complemented by regional distributors and manufacturers that provide comparable amino acid solutions. Navigating the procurement landscape demands meticulous attention to regulatory compliance, supply chain robustness, and product authenticity. Healthcare providers and pharmaceutical companies need to establish strategic supplier relationships, prioritize rigorous quality assurance, and remain adaptable to emerging alternative sources to ensure uninterrupted supply of this critical nutritional component.
Key Takeaways
- Baxter International Inc. is the primary and most recognized supplier of Trophamine 10%, with extensive global distribution channels.
- Regional manufacturers and comparable amino acid solutions from companies like Fresenius Kabi serve as alternatives, particularly where direct access to Baxter products is limited.
- Ensuring regulatory compliance and verifying supplier credibility are essential to prevent counterfeit risks and guarantee product safety.
- Supply chain resilience can be bolstered through diversified sourcing strategies, especially given the concentrated manufacturing capacity.
- Emerging trends include developing substitute amino acid solutions and customized formulations through regional providers or compounding pharmacies.
Frequently Asked Questions
1. Is Trophamine 10% available outside North America?
Yes. While Baxter predominantly supplies North America, regional distributors and manufacturers in Europe, Asia, and other regions also distribute Trophamine or similar amino acid solutions, subject to regional approvals and regulations.
2. Can alternative amino acid solutions replace Trophamine 10% in clinical practice?
Potentially, provided they meet comparable compositional and safety standards. Clinical validation and regulatory approvals are necessary before substitution.
3. What factors influence the pricing of Trophamine 10%?
Manufacturing costs, raw material availability, regulatory compliance costs, regional distribution logistics, and supply chain dynamics all impact pricing.
4. How can healthcare providers ensure the authenticity of Trophamine 10%?
By sourcing from authorized suppliers with validated supply chains, verifying certification documents, and conducting product identity verification upon receipt.
5. Are there any anticipated changes in the supply landscape of Trophamine 10%?
Potential future developments include manufacturing capacity expansions by existing producers, emergence of regional suppliers, and regulatory approvals for alternative formulations that could diversify supply sources.
References
- Baxter International Inc. Trophamine 10% Product Information. [Accessed 2023]
- European Medicines Agency. Pharmaceutical Standards for Amino Acid Solutions. [Accessed 2023]
- Fresenius Kabi Product Portfolio. [Accessed 2023]
- Indian Pharmacopeia. Amino Acid Injection Specifications. [Accessed 2023]
- Market Analysis Reports on Parenteral Nutrition Ingredients. [Accessed 2023]
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