Suppliers and packagers for AMINOSYN-PF 10%

AMINOSYN-PF 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
Otsuka Icu Medcl	AMINOSYN-PF 10%	amino acids	INJECTABLE;INJECTION	019492	NDA	ICU Medical Inc.	0990-4179-05	6 BAG in 1 CASE (0990-4179-05) / 1000 mL in 1 BAG	2019-11-01

Suppliers for the Pharmaceutical Drug: Aminosyn-PF 10%

Last updated: August 4, 2025

Introduction

Aminosyn-PF 10% is a specialized parenteral nutrition (PN) solution prominently used in clinical settings to deliver amino acids directly into the bloodstream of patients unable to obtain adequate nutrition orally or enterally. It is an integral component of hospital nutrition protocols, especially for critically ill or post-surgical patients. As a proprietary solution manufactured and distributed by key pharmaceutical suppliers, sourcing chemically and microbiologically safe formulations of Aminosyn-PF 10% is essential for healthcare providers worldwide. This article provides a comprehensive overview of leading suppliers, highlighting their roles, compliance standards, and what healthcare providers should consider when sourcing this vital nutritional product.

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Understanding Aminosyn-PF 10%

Aminosyn-PF 10%, produced by Fresenius Kabi, is a sterile, amino acid-based infusion designed to meet the protein needs of hospitalized patients. "PF" denotes the presence of phosphate and other electrolytes, and the “10%” indicates the concentration of amino acids (10 g per 100 mL). Its composition mimics human protein metabolism, aiding in tissue repair, immune function, and overall patient recovery.

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Major Suppliers of Aminosyn-PF 10%

Fresenius Kabi

Market Position & Profile:
Fresenius Kabi, a leading global healthcare company based in Germany, is the primary manufacturer of Aminosyn-PF 10%. The company specializes in critical care, infusion therapies, and clinical nutrition solutions. Fresenius Kabi is renowned for its commitment to quality, safety, and innovation in pharmaceutical manufacturing.

Supply Chain & Distribution:
The company maintains an extensive distribution network across North America, Europe, and Asia, ensuring timely availability for hospitals and clinics. Their global manufacturing facilities adhere to Good Manufacturing Practices (GMP), with certifications from the FDA, EMA, and other regulatory agencies.

Compliance & Quality Standards:
Aminosyn-PF 10% from Fresenius Kabi complies with USP, EP, and JP pharmacopeial standards. The company invests heavily in quality assurance, including rigorous sterility testing and quality control protocols.

Baxter International

Market Presence & Product Profile:
While Baxter's primary focus is on parenteral and enteral nutrition solutions, it supplies alternative amino acid solutions that may be used in similar protocols. Baxter’s inclusion here underscores the competitive landscape, although it does not manufacture Aminosyn-PF 10% specifically.

Alternative Products & Suppliers:
Baxter offers other amino acid solutions compatible with clinical nutrition requirements, including Aminosyn, Travasol, and Nutriflex. These products are trusted globally and adhere to strict regulatory standards.

Additional Suppliers and Distributors

While Fresenius Kabi remains the primary manufacturer, several regional and specialized distributors supply Aminosyn-PF 10%, especially in markets where direct procurement from Fresenius Kabi is limited.

1. McGuff Compounding
   Specialized compounding pharmacies in the US often prepare customized amino acid infusions, including formulations similar to Aminosyn-PF 10%, especially for patients with particular electrolyte or nutrient needs.

2. Henry Schein and Cardinal Health
   As prominent medical distributors, these firms procure and distribute Fresenius Kabi products, including Aminosyn-PF 10%, to hospitals and clinics globally.

3. Local and Regional Distributors
   Many countries have certified pharmaceutical wholesalers licensed to distribute Fresenius Kabi products locally, ensuring compliance with local regulations and facilitating supply chain security.

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Criteria for Selecting Suppliers

Healthcare providers should evaluate suppliers based on:

• Regulatory Compliance: Certification by FDA, EMA, or respective local agencies. GMP adherence ensures safety and efficacy.
• Product Authenticity: Verification of product authenticity to avoid counterfeit or substandard products.
• Supply Reliability: Proven track record of consistent supply, particularly during global disruptions, such as the COVID-19 pandemic.
• Quality Assurance: Investment in quality control processes, microbiological safety verification, and batch traceability.
• Pricing and Contract Terms: Competitive pricing aligned with procurement policies while preserving quality standards.

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Global Regulatory and Certification Landscape

The manufacturing and distribution of amino acid solutions like Aminosyn-PF 10% are tightly regulated. Suppliers must comply with pharmacopeial standards (USP, EP, JP) and hold certifications such as ISO 13485 for medical devices and Good Distribution Practices (GDP). Regulatory approval ensures the product's safety, potency, and sterility, which are non-negotiable in clinical nutrition.

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Emerging Trends and Future Outlook

• Localized Manufacturing: Countries increasingly favor regional manufacturing to mitigate supply chain disruptions.
• Regulatory Harmonization: Growing initiatives for global harmonization of standards enhance supplier credibility.
• Demand Growth: Rising incidences of critical illnesses and surgical interventions expand the demand for prolonged parenteral nutrition, boosting supplier roles.
• Innovation: Development of higher-concentration or tailored amino acid formulations to optimize patient outcomes.

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Conclusion

Fresenius Kabi remains the primary and most trusted supplier of Aminosyn-PF 10%, supported by a global network of distributors ensuring broad accessibility. While alternative providers exist, strict adherence to quality and regulatory standards is paramount. Healthcare facilities should meticulously vet suppliers, emphasizing compliance, product security, and supply reliability. As clinical nutrition continues to evolve, strategic sourcing of high-quality amino acid solutions like Aminosyn-PF 10% will be critical for optimizing patient outcomes and maintaining healthcare standards.

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Key Takeaways

• Primary Source: Fresenius Kabi is the main manufacturer of Aminosyn-PF 10%, emphasizing its importance as the gold-standard supplier.
• Supplier Evaluation: Tip the scales toward suppliers with rigorous quality assurance, regulatory compliance, and reliable supply chains.
• Regional Distributors: Many regional distributors facilitate access but must be vetted for authenticity and compliance.
• Regulatory Compliance: Always confirm that products meet local and international standards like USP, EP, and GMP certifications.
• Future Trends: Expect increased local manufacturing, innovation, and global regulatory harmonization to enhance supply security.

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Frequently Asked Questions

Q1. Is Aminosyn-PF 10% available outside the United States?
Yes, through authorized regional distributors and healthcare suppliers, primarily from Fresenius Kabi, which maintains an extensive international distribution network.

Q2. What should healthcare providers consider when sourcing Aminosyn-PF 10%?
Providers should prioritize certifications, product authenticity, supply chain reliability, and compliance with local regulations.

Q3. Are there alternatives to Aminosyn-PF 10%?
Yes, other amino acid solutions such as Travasol (Baxter) are available, but they differ in composition and usage protocols. It is essential to choose solutions based on clinical requirements and regulatory approval.

Q4. How does supply chain disruption affect access to Aminosyn-PF 10%?
Global disruptions, such as those caused by pandemics, can hinder procurement. Distributors with diversified manufacturing sources and regional facilities help mitigate these risks.

Q5. What is the impact of regulatory standards on supplier credibility?
Strict adherence ensures product safety and efficacy, making certified suppliers more trustworthy, especially in critical care contexts requiring sterile, high-quality nutritional solutions.

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References

1. Fresenius Kabi. (2022). Aminosyn-PF 10% Product Information.
2. United States Pharmacopeia (USP). Pharmacopoeial Standards for Parenteral Nutrition Solutions.
3. European Medicines Agency (EMA). Guidelines on the quality of infusion solutions.
4. Baxter International. Product Portfolio for Parenteral Nutrition.
5. Global Regulatory Framework for Medical Nutrition Products. (2021).