AMINOSYN II 15% IN PLASTIC CONTAINER: Pharmaceutical manufacturers, suppliers, and distributors

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Otsuka Icu Medcl	AMINOSYN II 15% IN PLASTIC CONTAINER	amino acids	INJECTABLE;INJECTION	020041	NDA	ICU Medical Inc.	0990-7171-17	6 POUCH in 1 CASE (0990-7171-17) / 1 BAG in 1 POUCH / 2000 mL in 1 BAG	2019-11-01
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: August 3, 2025

Introduction

In the pharmaceutical supply chain, sourcing reliable manufacturers for specialized products like AMINOSYN II 15% in plastic containers is critical. This parenteral amino acid solution is primarily used in parenteral nutrition (PN) for critically ill patients, necessitating stringent quality standards, regulatory compliance, and efficient logistics. Identifying credible suppliers ensures consistent availability, regulatory adherence, and product integrity.

Overview of AMINOSYN II 15% in Plastic Containers

AMINOSYN II 15% is an amino acid solution designed for intravenous administration, providing essential amino acids necessary for protein synthesis and metabolic maintenance. Packaged in plastic containers—typically flexible or rigid—these solutions are sterile, pyrogen-free, and manufactured under Good Manufacturing Practices (GMP).

The product’s stability, compatibility, and safety depend on material integrity of containers and precise aseptic manufacturing processes. The type of plastic container (e.g., PVC, polycarbonate, or polypropylene) influences compatibility, stability, and handling.

Key Criteria for Selecting Suppliers

When evaluating suppliers for AMINOSYN II 15% in plastic containers, critical factors include:

Regulatory Compliance: Adherence to USP, EP, and FDA standards.
Manufacturing Capacity: Ability to meet global demand with consistent quality.
Quality Assurance: Robust quality control and stability protocol.
Supply Chain Reliability: Logistics, lead times, and inventory management.
Packaging Specifications: Compatibility and container integrity.
Pricing & Contract Terms: Competitive pricing aligned with market standards.

Major Suppliers and Manufacturers

1. B. Braun Melsungen AG

B. Braun is a leading manufacturer of intravenous solutions, including amino acid products. Their “Aminosyn” portfolio includes Aminosyn II 15%, supplied in various container types, including plastics. Known for rigorous GMP compliance and extensive international distribution, B. Braun’s offerings are widely used worldwide, particularly in North America and Europe.

Key Points:

Extensive manufacturing facilities aligned with regulatory standards.
Multiple container options, including plastic bags or bottles.
Recognized for high product quality and reliable supply.

2. Fresenius Kabi

Fresenius Kabi specializes in infusion therapies and parenteral nutrition solutions, producing Aminosyn II series in sterile, plastic containers. Their manufacturing processes adhere to global standards, and they are a trusted supplier in hospitals and healthcare networks globally.

Key Points:

Global manufacturing footprint.
Focus on patient safety and stability.
Offers customer support and regulatory assistance.

3. Baxter International Inc.

Baxter produces a suite of parenteral nutrition solutions, with Aminosyn series recognized for quality and stability. Their Aminosyn II in plastic containers—ranging from single-dose vials to bags—are designed for compatibility and ease of administration.

Key Points:

Extensive distribution network.
Strong focus on compliance and product efficacy.
Innovative container designs enhancing stability.

4. CMIC (China Medicinal International Corporation)

CMIC manufactures amino acid solutions, including Aminosyn II 15%, primarily for Asian and international markets. Their products meet ISO standards and are increasingly adopted in emerging markets.

Key Points:

Competitive pricing.
Wide availability, particularly in Asia-Pacific.
Growing recognition for quality compliance.

5. Local and Regional Suppliers

Multiple regional manufacturers and distributors offer Aminosyn II 15% in plastic containers, particularly in Europe, Asia, and South America. Many of these are licensed or authorized by the original patent holders or operate under local GMP standards to meet regional regulations. Engaging with regional suppliers can reduce lead times and shipping costs but requires due diligence in quality verification.

Emerging and Alternative Suppliers

Hospira (a Pfizer company): Offers amino acid solutions aligned with Pfizer’s portfolio, focusing on stability and container performance.
Sandoz (Novartis): Provides generic IV solutions, including amino acid drugs, with an emphasis on quality control.
Local suppliers and brokers: Often private label or regional manufacturers who meet high standards, especially in markets like India, China, and Eastern Europe.

Regulatory Considerations

Suppliers must comply with:

FDA regulations (21 CFR Part 201 and 600 series) for US markets.
European Pharmacopoeia (EP) standards.
WHO prequalification for global access.
ISO certifications (ISO 13485).

Ensuring suppliers possess valid manufacturing and distribution licenses, alongside successful audits, is vital to maintain product integrity.

Supply Chain Dynamics and Risk Management

Dependence on a limited number of suppliers increases vulnerability. Diversifying sources—establishing relationships with multiple manufacturers—mitigates risks like supply disruptions, recalls, or regulatory non-compliance. The ongoing digital transparency and supplier audits are integral to maintaining a reliable supply chain.

Future Trends in Supplier Selection

Adoption of Single-Use Bioprocessing: Transition to advanced plastic containers (e.g., ethylene vinyl acetate, EVA) enhances product stability.
Regional manufacturing expansion: To meet local demand and reduce geopolitical risks.
Enhanced quality partnerships: Collaboration with leading suppliers to ensure regulatory compliance.
Sustainability considerations: Preference for eco-friendly packaging solutions.

Key Takeaways

Reliable sourcing of AMINOSYN II 15% in plastic containers relies on verifying adherence to global regulatory standards, manufacturing quality, and supply chain resilience.
Major global suppliers include B. Braun, Fresenius Kabi, and Baxter, supported by regional manufacturers.
Understanding container compatibility and stability considerations is critical in supplier selection.
Diversifying suppliers and ensuring ongoing quality audits mitigate risks.
Emerging trends favor eco-friendly packaging and regional manufacturing to address market-specific needs.

Frequently Asked Questions (FAQs)

1. Who are the primary global manufacturers of AMINOSYN II 15% in plastic containers?
Major global producers include B. Braun Melsungen, Fresenius Kabi, and Baxter International, all recognized for their adherence to international regulatory standards and supply reliability.

2. What are critical factors to consider when sourcing AMINOSYN II in plastic containers?
Key factors include regulatory compliance, product quality, supply chain robustness, container compatibility, and cost efficiency.

3. Are there regional suppliers offering equivalent amino acid solutions?
Yes, regional manufacturers in Asia, Europe, and South America produce amino acid solutions meeting quality standards, often at lower costs but requiring meticulous verification of compliance.

4. How does container material impact the stability and safety of AMINOSYN II?
Plastic containers must be chemically compatible with amino acid solutions to prevent leaching, contamination, or instability, ensuring safe intravenous administration. Material standards influence the shelf life and integrity of the product.

5. What future developments can improve the supply of amino acid solutions like AMINOSYN II?
Advances include regional manufacturing, sustainable packaging, and enhanced logistics tracking, reducing lead times and improving supply security.

References

[1] U.S. Food and Drug Administration (FDA). Code of Federal Regulations, Title 21, Part 201 and 600 series.
[2] European Pharmacopoeia (EP). Monograph standards for amino acid solutions.
[3] World Health Organization (WHO). Prequalification Program for Parenteral Nutrition Solutions.
[4] B. Braun Melsungen AG Product Portfolio.
[5] Fresenius Kabi Product Catalog.

This comprehensive guide assists healthcare providers, procurement professionals, and industry stakeholders in identifying and evaluating suppliers for AMINOSYN II 15% in plastic containers, ensuring quality, compliance, and supply stability.

Suppliers and packagers for AMINOSYN II 15% IN PLASTIC CONTAINER