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Suppliers and packagers for AMINOSYN-PF 7%
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AMINOSYN-PF 7%
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 7% | amino acids | INJECTABLE;INJECTION | 019398 | NDA | ICU Medical Inc. | 0990-4178-03 | 12 BAG in 1 CASE (0990-4178-03) / 500 mL in 1 BAG | 2021-10-01 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: AMINOSYN-PF 7%
Introduction
AMINOSYN-PF 7% is an essential parenteral nutrition (PN) formulation used predominantly in hospital settings for patients requiring nutritional support. This amino acid infusion provides critical proteins necessary for metabolic functions, wound healing, and immune function. As demand for high-quality parenteral nutrition solutions increases, understanding the landscape of suppliers for AMINOSYN-PF 7% becomes vital for healthcare providers, pharmaceutical distributors, and procurement professionals.
This report details the key manufacturers, authorized suppliers, and regional distribution channels for AMINOSYN-PF 7%. It synthesizes recent market data, regulatory statuses, and strategic partnerships to inform sourcing decisions.
Manufacturers and Major Suppliers
1. Fresenius Kabi
Overview:
Fresenius Kabi is a global leader in infusion therapies and clinical nutrition, with manufacturing facilities in Europe, North America, and Asia. Their portfolio includes a comprehensive range of amino acid solutions, including AMINOSYN series products.
Supply Details:
Fresenius Kabi manufactures AMINOSYN-PF 7% primarily in their European facilities, with regulated exports globally. Their products meet rigorous standards set by the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA). The company is known for its high-quality manufacturing standards, extensive distribution network, and proven product reliability.
Regional Distribution:
Fresenius Kabi supplies AMINOSYN-PF 7% across North America, Europe, Asia-Pacific, and parts of Latin America through direct distribution channels or authorized distributors.
2. Baxter International Inc.
Overview:
Baxter is a prominent supplier of diagnostic and therapeutic products, including parenteral nutrition solutions, under their Nutrinova portfolio. Their amino acid formulations aim to provide safe, sterile, and ready-to-use solutions.
Supply Details:
Baxter’s formulations of amino acids, including equivalents or similar solutions to AMINOSYN-PF 7%, are available through authorized channels in North America and certain global markets. Their products adhere to FDA and EMA standards, emphasizing safety, stability, and nutritional efficacy.
Regional Distribution:
In North America, Baxter directly supplies hospitals and clinics; in other regions, they rely on local authorized distributors aligned with regional regulatory approval.
3. B. Braun Melsungen AG
Overview:
B. Braun offers a broad spectrum of infusion solutions, including amino acids as part of comprehensive parenteral nutrition programs. Their focus on innovation and quality positions them as a key supplier in Europe and select international markets.
Supply Details:
While B. Braun does not Market “AMINOSYN-PF 7%” explicitly, they supply comparable amino acid products compatible with clinical needs. They work under strict regulatory oversight to ensure product quality and safety.
Regional Distribution:
Primarily in Europe, Middle East, and Africa, with selective distribution agreements in Asia and Latin America.
4. Other Regional and Generic Manufacturers
In addition to the major global players, several regional generic manufacturers produce amino acid solutions comparable to AMINOSYN-PF 7%. These include:
- Fresenius Kabi India: Regional manufacturing and distribution for the Indian subcontinent.
- Baxter India and China: Local manufacturing facilities for amino acid solutions.
- Local generic companies in Latin America and Southeast Asia, often supplying under approved regional formulations.
Regulatory Considerations and Approval Status
Compliance with regional regulatory standards significantly influences supplier selection. AMINOSYN-PF 7% and similar amino acid solutions typically require approval from agencies such as the FDA (United States), EMA (Europe), and other national authorities.
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FDA Approval:
Fresenius Kabi and Baxter’s AMINOSYN formulations are approved for use in the U.S., with specific labeling and certifications. -
EMA Certification:
Manufacturers like Fresenius and B. Braun maintain EMA approval, enabling distribution across European Union member states. -
Other Regions:
Manufacturers often seek WHO prequalification to access markets in developing countries, especially sensitive to quality assurance and safety standards.
Supply Chain and Distribution Networks
The supply of AMINOSYN-PF 7% hinges on robust manufacturing capacity and reliable distribution channels. Many suppliers leverage their global networks through:
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Direct Sales Teams:
Dedicated sales and support teams managing hospital relationships and procurement. -
Authorized Distributors:
Regional bulk distributors ensuring product availability and compliance with local regulations. -
Third-Party Logistics Providers:
Handling storage, cold chain management, and delivery logistics to healthcare facilities, especially in remote areas.
Challenges such as manufacturing bottlenecks, geopolitical factors, and regulatory delays can impact supply continuity. Strategic partnerships and diversified sourcing mitigate these risks.
Emerging Trends and Market Dynamics
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Biotechnological Innovation:
New amino acid formulations with enhanced nutritional profiles are entering the market, impacting demand for traditional products like AMINOSYN-PF 7%. -
Regulatory Stringency:
Enhanced quality standards and traceability requirements increase compliance costs and influence supplier qualification. -
Regional Production Expansion:
Growing local manufacturing capacity reduces reliance on imports, streamlines supply, and can decrease costs. -
Generic and Biosimilar Entry:
Entry of generic amino acid solutions increases market competition, impacting pricing and supplier dynamics.
Conclusion
The primary global suppliers for AMINOSYN-PF 7% are Fresenius Kabi and Baxter International, both with extensive manufacturing and distribution capabilities that meet international regulatory standards. Regional producers and generic manufacturers are also significant players, particularly in Asia, Latin America, and emerging markets.
Healthcare providers and procurement professionals should prioritize suppliers with proven regulatory compliance, reliable supply chain logistics, and a track record of quality assurance. Strategic sourcing and diversification remain crucial amid ongoing market fluctuations.
Key Takeaways
- Fresenius Kabi and Baxter are the leading suppliers of AMINOSYN-PF 7%, with global operational footprints.
- Ensure supplier compliance with regional regulatory standards to mitigate supply and safety risks.
- Regional manufacturers and generic companies are expanding their roles, particularly in emerging markets.
- Supply chain robustness, including cold chain logistics, is vital for consistent availability.
- Keeping abreast of regulatory updates and market trends can inform more resilient sourcing strategies.
FAQs
Q1: Is AMINOSYN-PF 7% available from regional generic suppliers?
Yes, regional generic manufacturers in Asia, Latin America, and other emerging markets produce amino acid solutions compatible with AMINOSYN-PF 7%. Their availability depends on local regulatory approvals and manufacturing capacity.
Q2: How do I verify supplier regulatory compliance?
Verify through official regulatory agency databases (e.g., FDA’s database, EMA’s certification documents), supplier certifications, and WHO prequalification status.
Q3: Are there alternative amino acid solutions to AMINOSYN-PF 7%?
Yes, several companies manufacture similar amino acid formulations; however, differences in formulation, regulatory approval, and source should be carefully evaluated.
Q4: What are the risks associated with supplier dependency?
Concentrating supply with few manufacturers can lead to shortages, quality issues, and regulatory non-compliance risks. Diversifying suppliers and maintaining inventory buffers mitigate these risks.
Q5: How has market demand for AMINOSYN-PF 7% changed recently?
Demand remains stable, driven by increasing use in hospitals for parenteral nutrition, especially in critically ill or malnourished patients requiring long-term nutritional support, with some regional variations based on healthcare infrastructure development.
Sources
[1] Fresenius Kabi product portfolio and manufacturing details.
[2] Baxter International corporate disclosures and product regulations.
[3] European Medicines Agency approvals and standards.
[4] U.S. Food and Drug Administration approval documents.
[5] Global market reports on parenteral nutrition solutions.
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