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: June 3, 2026

Executive summary: Aminosyn II 15% (an injectable amino acid solution used in parenteral nutrition) is typically supplied by established sterile injectables manufacturers under FDA-regulated cGMP. The supply network is layered: (1) drug product manufacturers who fill and finish the sterile amino acid solution into plastic containers, (2) primary raw-material suppliers (amino acid building blocks, buffering agents, electrolytes when present, nitrogen sources, and pH modifiers), (3) polymer/container suppliers for the “plastic container” (most commonly EVA-based or other IV-compatible film systems, depending on the specific container design), and (4) distributors and wholesalers that cover hospital, specialty pharmacy, and home-infusion demand.

No definitive, authoritative supplier list can be produced from the information provided (product name alone does not identify the exact NDA holder/labeler, the specific container configuration tied to that label, or the current manufacturing sites).

Who makes AMINOSYN II 15% in plastic container and what “supplier” means in practice?

Answer: “Suppliers” for Aminosyn II 15% can include four distinct groups: the FDA labeler (NDA holder or applicant), the contract sterile manufacturer/fill-finish site, the raw-material vendors for amino acids and excipients, and the plastic container manufacturers.

Drug product labeler vs contract manufacturer

The FDA labeler for an injectable product is the entity responsible for the labeled product under the approved marketing application (commonly the NDA holder).
Actual sterile fill-finish may be performed at one or more contract manufacturing sites.
“Supplier” in procurement terms can mean either the labeler or the specific manufacturing site listed in quality agreements and vendor onboarding documentation.

Raw-material suppliers that matter for amino acid solutions

Aminosyn-type amino acid products typically depend on:

Individual amino acid raw materials (pharmaceutical grade)
Buffering system and pH adjusters (to hit osmolarity and pH specifications)
Stabilizers/excipients as defined in the specific label
Sterile filtration and bioburden control consumables
Container closure system materials, including additives that prevent incompatibilities with the container film

Procurement due diligence usually focuses on:

DMF-linked supplier status for key amino acids
Traceability and batch-to-batch qualification
Compatibility studies between the formulation and the plastic container system

Plastic container suppliers for IV amino acid solutions

“Plastic container” generally means:

A flexible IV container film and seams that are compatible with amino acid solutions
A closure system and port components that meet elastomer compatibility and extractables/leachables requirements
Container systems that support sterilization and maintain product integrity through shelf life

In practice, container supply is often a specialized component market with a limited number of qualified suppliers that meet extractables and leachables profiles for aqueous IV solutions.

What suppliers provide the amino acid raw materials used in AMINOSYN II 15%?

Answer: The suppliers are upstream specialty chemical companies and amino acid manufacturers whose products meet pharmaceutical-grade specifications and are qualified for injectable use. The exact names depend on the approved formulation and the current qualification status for the specific NDA label.

Key upstream input categories

Amino acid monomers (various L-forms depending on the formula)
Nitrogen and carbon sources where relevant to the manufacturing route
Excipients that control pH and osmolarity
Water-for-injection and sterile manufacturing consumables

How procurement teams typically identify qualifying suppliers

Review the drug substance and excipient qualification packages supplied to quality assurance
Match vendor CoA/specs to the product’s validated specifications
Confirm whether key raw materials are sourced from DMF-authorized suppliers (where applicable)

Which companies supply the plastic IV containers for amino acid injectable solutions?

Answer: Plastic container suppliers are container system manufacturers and component vendors that provide qualified IV film systems and closures. The specific suppliers depend on the exact container configuration used for the Aminosyn II 15% labeling and the manufacturing site’s approved container list.

What to verify in the container supplier package

Extractables/leachables assessments for aqueous amino acid solutions
Compatibility testing for pH, ionic strength, and storage conditions
Closure/port integrity and compatibility with sterile manufacturing procedures
Serial/batch traceability and change control compliance

How do distributors and wholesalers affect who you buy from?

Answer: Even when the labeler and manufacturing site are fixed, hospitals, group purchasing organizations, and wholesalers determine the “supplier” that appears on purchase orders and contracts.

Typical distribution channels

National and regional wholesalers supplying hospitals and infusion centers
Specialty distributors for home infusion and specialty pharmacy channels
Contract distribution under group purchasing or GPO arrangements

Procurement outcomes often depend on:

Wholesaler inventory availability
Allocation policies during manufacturing outages
Contract terms tied to labeler and NDC-level supply continuity

What regulatory records determine the true supplier list for AMINOSYN II 15%?

Answer: The definitive supplier identification comes from regulatory and labeling artifacts that map labeler, manufacturer (including site), and NDC-level packaging.

Where to look for supplier identity in FDA-linked data

The product label for the current NDC presentation and container type
The FDA listing of drug establishments for manufacturing activities
Any FDA inspection and enforcement records tied to manufacturing sites
If relevant for the market, FDA submissions tied to changes in manufacturer or packaging

Key Takeaways

“Suppliers” for Aminosyn II 15% in plastic container span labeler, sterile fill-finish manufacturer, raw-material vendors, and plastic container system suppliers.
The exact company list cannot be determined from the product name alone because the labeler, NDC presentation, and current manufacturing sites determine the supplier roster.
Procurement-quality due diligence should map supplier identity to the labeled product’s NDC, the approved manufacturer sites, and the qualified container system list.

FAQs

How do I identify the actual fill-finish manufacturer for Aminosyn II 15% beyond the labeler name?
What documentation should a container supplier provide for an IV amino acid solution’s extractables/leachables compliance?
How can hospitals verify that upstream amino acid and excipient suppliers are qualified for injectable use?
What supply-chain bottlenecks typically affect amino acid injectable products in plastic containers?
How do NDC-level packaging changes alter supplier qualification for Aminosyn II 15%?

References (APA)

U.S. Food and Drug Administration. (n.d.). FDA Drug Establishment Registration and Drug Listing (public data and records). https://www.fda.gov/
U.S. Food and Drug Administration. (n.d.). Drug approvals and labeling (access via Drugs@FDA and NDC label information). https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm

Suppliers and packagers for AMINOSYN II 15% IN PLASTIC CONTAINER