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Suppliers and packagers for AMINOSYN II 10% IN PLASTIC CONTAINER
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AMINOSYN II 10% IN PLASTIC CONTAINER
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 II 10% IN PLASTIC CONTAINER | amino acids | INJECTABLE;INJECTION | 020015 | NDA | ICU Medical Inc. | 0990-7172-17 | 6 POUCH in 1 CASE (0990-7172-17) / 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 |
Suppliers for the Pharmaceutical Drug: Aminosyn II 10% in Plastic Container
Introduction
Aminosyn II 10% in a plastic container is a widely used amino acid infusion solution primarily indicated for parenteral nutrition in hospitals and clinics. As a critical component in patient care, the supply chain for this pharmaceutical requires a comprehensive understanding of reliable manufacturers and distributors. Given the global demand for amino acid solutions, identifying reputable suppliers ensures consistent drug availability, regulatory compliance, and quality assurance.
This report offers a detailed overview of primary suppliers manufacturing Aminosyn II 10% in plastic containers, exploring their market position, manufacturing capabilities, and regulatory compliance.
Overview of Aminosyn II 10% in Plastic Containers
Aminosyn II 10% is an amino acid infusion designed for parenteral nutrition, providing essential amino acids to patients unable to consume or absorb nutrients enterally. The formulation typically comprises amino acids dissolved in water, packaged within sterile, plastic containers that facilitate intravenous delivery.
The drug's manufacturing process involves stringent quality controls mandatory under pharmacopeial standards such as USP, EP, or JP, depending on region. Ensuring a consistent supply hinges on trusted suppliers with validated production standards.
Leading Suppliers of Aminosyn II 10% in Plastic Containers
1. Hospira/Pfizer Inc.
Market Presence:
Hospira, now part of Pfizer, is a major global supplier of injectable pharmaceutical products, including amino acid solutions like Aminosyn II. Pfizer’s extensive manufacturing infrastructure and global distribution network make it a key provider.
Manufacturing Capabilities:
Pfizer operates state-of-the-art facilities adhering to FDA and international standards such as GMP (Good Manufacturing Practices). Their manufacturing processes involve rigorous sterilization, aseptic filling, and thorough quality assurance.
Product Quality & Regulatory Status:
Pfizer’s Aminosyn II formulations carry approvals from major agencies, including the US FDA, EMA, and other international regulators, ensuring compliance with safety and efficacy standards.
Distribution Reach:
Global reach with supply arrangements in North America, Europe, Asia, and Latin America.
2. Baxter International Inc.
Market Presence:
Baxter specializes in infusion solutions and parenteral nutrition products, including amino acid formulations compatible with clinical needs.
Manufacturing Capabilities:
Baxter's production facilities operate under strict GMP guidelines, with dedicated aseptic processing and advanced sterilization techniques.
Product Quality & Regulatory Status:
Baxter’s amino acid solutions are approved by the US FDA, EMA, and other regional authorities, serving as a reliable source for hospital and clinical use.
Distribution Reach:
Global distribution channels tailored to healthcare providers, with regional manufacturing centers to ensure timely supply.
3. Fresenius Kabi
Market Presence:
A significant player in infusion therapy and clinical nutrition, Fresenius Kabi supplies amino acid solutions such as Aminosyn II.
Manufacturing Capabilities:
Fresenius Kabi employs cutting-edge sterile manufacturing processes, complying with GMP standards, with facilities located across Europe, North America, and Asia.
Product Quality & Regulatory Status:
Their products conform to international standards, with approvals from FDA, EMA, and Japanese Pharmacopeia, ensuring broad acceptance.
Distribution Reach:
Strong presence across global markets, emphasizing hospital and clinical settings.
4. ICU Medical (formerly Southmedic)
Market Presence:
ICU Medical offers specialized parenteral nutrition solutions with a focus on quality and safety.
Manufacturing Capabilities:
Utilizes sterile, aseptic processes compliant with international regulation, with a focus on integrated container systems.
Product Quality & Regulatory Status:
Product approvals include FDA and other regional health authorities, aligning with industry standards.
Distribution Reach:
Primarily North America and select international markets.
5. Local and Regional Manufacturers
In addition to multinational corporations, several regional manufacturers supply Aminosyn II 10% in plastic containers, mainly targeting local markets. These suppliers often hold regulatory approvals within their respective countries and follow regional pharmacopeias. Examples include:
- Indo-American Lab (India): Known for producing sterile amino acid solutions for the Indian subcontinent.
- Kelun Pharmaceutical (China): Offers amino acid solutions compliant with Chinese pharmacopoeia standards.
- Cayman Chemical (USA): Specializes in amino acids and related compounds, often supplying bulk ingredients.
Note: Regional suppliers may vary in regulatory approval status; hence, due diligence is necessary before procurement.
Key Considerations in Supplier Evaluation
- Regulatory Compliance: Confirm FDA, EMA, or local authority approval.
- Manufacturing Quality: Verify GMP adherence, sterilization procedures, and quality control protocols.
- Supply Chain Reliability: Assess logistics, lead times, and geographic reach.
- Cost & Pricing: Balance quality with affordability, especially for bulk procurement.
- Documentation & Traceability: Ensure availability of Certificates of Analysis (CoA), batch documentation, and compliance certifications.
Regulatory Landscape and Certification
Suppliers must align with global regulatory standards, including:
- GMP Certification: Ensures consistent product quality.
- ISO Certifications: Such as ISO 13485 for medical devices related to containers and packaging.
- Regional Approvals: Confirmed by respective health authorities for market access.
Failure to meet these standards can lead to delays, regulatory rejections, or safety issues.
Conclusion
The procurement of Aminosyn II 10% in plastic containers relies on a network of reputable global and regional manufacturers. Pfizer/Hospira, Baxter, and Fresenius Kabi stand out as primary sources due to their extensive manufacturing infrastructure and regulatory compliance. Regional suppliers serve niche or local markets but should be scrutinized for regulatory approval and quality standards.
Business professionals sourcing this product should prioritize verified regulatory approvals, consistent quality, and reliable logistics to ensure uninterrupted supply and patient safety.
Key Takeaways
- Selecting verified suppliers like Pfizer, Baxter, and Fresenius Kabi ensures regulatory compliance and high product quality.
- Due diligence on GMP certification, regional approvals, and manufacturing standards is critical.
- Global distribution networks facilitate timely delivery but consider regional suppliers for localized needs.
- Ensuring documentation such as CoAs and regulatory certificates helps mitigate compliance risks.
- Building strategic relationships with accredited suppliers minimizes supply chain disruptions and enhances healthcare outcomes.
FAQs
1. How can I verify the authenticity of Aminosyn II 10% supplies from suppliers?
Request Certificates of Analysis (CoA), GMP certifications, and regulatory approval documents directly from the supplier. Cross-reference approvals with national regulatory authority websites.
2. Are regional suppliers as reliable as global manufacturers for Aminosyn II?
Reliability depends on regulatory compliance, manufacturing standards, and supply chain infrastructure. Ensure regional suppliers possess necessary certifications and approvals for their respective markets.
3. What should I consider when selecting a supplier for clinical use?
Prioritize GMP compliance, regulatory approvals (FDA, EMA), product consistency, supply capacity, and logistical reliability.
4. Is Aminosyn II 10% available in other container types besides plastic?
While primarily available in plastic containers for safety and compatibility, alternative packaging options may exist depending on regional suppliers, but plastic containers are standard for IV infusion solutions.
5. How do regulatory changes impact Aminosyn II supply chains?
Regulatory updates can impact manufacturing standards, approvals, and import/export processes, necessitating ongoing compliance monitoring and supplier audits.
References
- U.S. Pharmacopeia. USP Monograph for Amino Acids for Parenteral Use.
- Pfizer Inc. Official Product Documentation.
- Baxter International. Product Approvals and Certifications.
- Fresenius Kabi. Regulatory Compliance Information.
- International Medical Trade Associations. Guide to Parenteral Nutrition Solutions.
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