Suppliers and packagers for TROPHAMINE

TROPHAMINE

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	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

Suppliers for the Pharmaceutical Drug: TROPHAMINE

Last updated: August 1, 2025

Introduction

Trophamine, a proprietary amino acid solution used primarily in neonatal and pediatric nutrition, is manufactured by established pharmaceutical and nutritional companies. Due to its specialized application, sourcing reliable suppliers requires detailed understanding of the supply chain, manufacturer reputations, and regulatory compliance. This report provides a comprehensive overview of key suppliers of Trophamine, their market positions, and factors influencing procurement decisions to facilitate strategic sourcing.

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Overview of Trophamine

Trophamine is a medically significant amino acid supplement formulated primarily for parenteral nutrition (PN) in vulnerable populations such as neonates and premature infants. Its formulation provides essential amino acids optimized for growth and development, with a focus on bioavailability and compatibility with intravenous administration. The pharmaceutical-grade quality of Trophamine underscores its importance in clinical settings, necessitating sourcing from reputable suppliers with stringent quality assurance.

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Major Suppliers of Trophamine

1. Fresenius Kabi

   • Market Position: Fresenius Kabi is a leading global pharmaceutical company specializing in infusion therapies, clinical nutrition, and IV medications. The company's extensive portfolio includes Trophamine, which is majorly supplied under the Fresenius Kabi brand.

   • Product Details: Fresenius Kabi manufactures Trophamine as part of its comprehensive neonatal parenteral nutrition solutions. It emphasizes product quality, sterile manufacturing processes, and adherence to global regulatory standards such as FDA, EMA, and WHO.

   • Supply Chain and Distribution: As a global leader, Fresenius Kabi maintains a robust distribution network across North America, Europe, and Asia, ensuring reliable availability in multiple markets. Their global footprint and GMP compliance make them a primary candidate for procurement in healthcare institutions worldwide.

   • Regulatory and Quality Certifications: Certifications include ISO 13485, cGMP compliance, and approval from relevant health authorities, assuring high safety and efficacy standards.

2. Baxter International

   • Market Position: Baxter is another prominent supplier with a significant presence in clinical nutrition and infusion therapy. Although Baxter primarily markets its own parenteral nutrition products, it also supplies specialized amino acid solutions compatible with neonatal care.

   • Product Details: Baxter offers amino acid solutions similar in composition and purpose to Trophamine, often in combination with other nutrients for comprehensive PN therapy.

   • Supply Chain and Distribution: Baxter’s extensive global manufacturing and distribution network facilitates dependable supply in North America, Europe, Asia, and other regions.

   • Regulatory & Quality: Baxter’s manufacturing facilities hold necessary approvals such as FDA, EMA, and other regulatory bodies, emphasizing quality control in its products.

3. Vifor Pharma (Fresenius Vifor)

   • Market Position: Vifor Pharma, acquired by Fresenius, supplies amino acids and nutritional solutions, sometimes acting as a distributor or co-developer for products like Trophamine in specific markets.

   • Role in Supply Chain: Collaborates with Fresenius Kabi and other manufacturers to streamline global distribution, especially in emerging markets.

4. Other Regional and Contract Manufacturers

   • Smaller pharmaceutical companies or Contract Manufacturing Organizations (CMOs) may produce Trophamine under licensing agreements. These are typically region-specific, often serving local markets to meet regulatory and supply demands.

   • Examples: Local providers in developing countries, or companies accredited by global regulatory bodies, may serve niche markets or act as authorized generic manufacturers.

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Manufacturing and Regulatory Considerations

Procurement of Trophamine hinges on compliance with regulatory standards. Suppliers must demonstrate adherence to good manufacturing practices (GMP), sterility assurance, and consistent product quality. Certification from agencies like the FDA (United States), EMA (Europe), and TGA (Australia) ensures product integrity. International standards such as ISO 13485 further establish quality management systems.

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Supply Chain Challenges and Strategies

• Global Supply Disruptions: The COVID-19 pandemic underscored vulnerabilities in global pharmaceutical supply chains, affecting availability and pricing.

• Regulatory Variations: Differing approval processes across countries may influence supplier selection, requiring local regulatory insights.

• Price and Contract Negotiation: Competitive bidding often occurs among primary suppliers, with long-term contracts preferable to ensure stable supply.

• Bulk Procurement and Inventory Management: Large healthcare institutions or governments often negotiate volume discounts and establish safety stock levels with key suppliers like Fresenius Kabi and Baxter.

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Emerging Trends in Supplier Selection

• Diversification: To mitigate risks, sourcing from multiple suppliers or regional manufacturers is advisable.

• Local Production: Countries with expanding healthcare infrastructure focus on developing local manufacturing capacity to reduce dependency on imports.

• Regulatory Harmonization: Initiatives such as the International Conference on Harmonisation (ICH) aim to streamline approvals, benefiting global supply coordination.

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Conclusion

Fresenius Kabi remains the most prominent and reliable global supplier of Trophamine, backed by extensive manufacturing capabilities, regulatory compliance, and widespread distribution. Baxter International also offers comparable amino acid solutions suitable in clinical settings. Other regional or specialized manufacturers play roles in localized markets. Healthcare providers and procurement professionals should prioritize suppliers with verified GMP practices, regulatory approvals, and robust supply chains to ensure consistent access to this critical neonatal nutrition product.

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Key Takeaways

• Fresenius Kabi dominates as the primary global provider of Trophamine, ensuring high standards and wide availability.
• Regulatory compliance and product quality certifications are crucial factors when selecting Trophamine suppliers.
• Diversification of sources mitigates risks associated with supply disruptions, especially amid global logistical challenges.
• Contract negotiations should prioritize long-term stability, volume discounts, and logistical reliability.
• Emerging regional manufacturers can supplement primary suppliers to enhance supply security.

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FAQs

Q1: What distinguishes Fresenius Kabi as a primary supplier of Trophamine?
A: Fresenius Kabi’s extensive manufacturing capacity, global regulatory approvals, stringent quality management, and widespread distribution networks position it as the leading supplier of Trophamine globally.

Q2: Are there regional alternatives to Fresenius Kabi for sourcing Trophamine?
A: Yes, some regional companies or contract manufacturers produce amino acid solutions compatible with neonatal PN, but their availability depends on local regulatory approvals and manufacturing standards.

Q3: What are key considerations when selecting a Trophamine supplier?
A: Critical factors include GMP compliance, regulatory approvals, product consistency, supply chain reliability, and the ability to meet demand volume.

Q4: How has the COVID-19 pandemic impacted the supply of Trophamine?
A: The pandemic exposed vulnerabilities in global pharma supply chains, leading to shortages and delays. Diversifying suppliers and maintaining safety stocks are recommended mitigation strategies.

Q5: Can local manufacturers produce Trophamine?
A: While some countries develop or produce amino acid solutions locally, these often require rigorous certification and validation processes to match global standards, limiting immediate availability but offering strategic redundancy.

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References

[1] Fresenius Kabi Official Website. (2023). Neonatal Nutrition & Parenteral Nutrients.
[2] Baxter International Reports. (2022). Clinical Nutrition Product Portfolio.
[3] World Health Organization. (2017). Guidelines on the manufacturing of sterile medicinal products.
[4] Regulatory Affairs Documents. (2021). International Harmonization in Pharmaceutical Production.