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 and packagers for AMINOSYN-PF 10%

Last updated: May 31, 2026

AMINOSYN-PF 10% suppliers: who manufactures, supplies, and distributes the amino acid injection in the US

AMINOSYN-PF 10% is an amino acid injection (10% w/v) used for parenteral nutrition. The supplier landscape is constrained by how the product is approved, packaged, and distributed in the US (single-NDC supply chain, wholesaler distribution, and pharmacy/health-system purchasing channels). The next sections identify supplier roles and the most common sourcing routes for Aminosyn-PF 10% procurement.

Who are the suppliers of AMINOSYN-PF 10% in the US supply chain?

Answer: Aminosyn-PF 10% is supplied through the US wholesaler distribution network under the product’s approved label and NDC(s); the manufacturer listed on the FDA label/Orange Book governs upstream supply, while wholesalers and authorized distributors sell into hospitals, IDNs, and specialty pharmacies.

Upstream: manufacturer vs. labeler vs. authorized distributor

For injectable parenteral nutrition products like AMINOSYN-PF 10%, procurement typically maps to:

• Label holder / manufacturer (ND C-level): the entity responsible for GMP supply under the approved NDA/label listing.
• Authorized distributors: companies that buy product from the labeler/manufacturer and resell to customer channels (acute care, long-term care, home infusion).
• Wholesalers: large national drug distributors that stock and deliver to providers.
• Hospital group purchasing organizations (GPOs) and contract distributors: may re-bundle sourcing and delivery even when they do not manufacture.

Common buyer-facing supply channels for AMINOSYN-PF 10%

• Hospital pharmacy supply (GPO contracts, wholesaler drop-ship)
• Home infusion supply for selected parenteral nutrition regimens
• Long-term care pharmacy distribution
• Specialty compounding pharmacies only if they are sourcing the FDA-approved product for admixture (not reformulating the drug)

What is the FDA-listed manufacturer and labeler for AMINOSYN-PF 10%?

Answer: The FDA labeler/manufacturer is the controlling upstream supplier for AMINOSYN-PF 10%.

For an authoritative supplier mapping, the manufacturer is identified from:

• FDA “Drug Label Information” and SPL label for AMINOSYN-PF 10%
• Orange Book and/or NDA listing linked to the approved amino acid injection product
• NDC directory for the product’s labeler and package configuration

Which wholesalers supply AMINOSYN-PF 10% to hospitals and health systems?

Answer: AMINOSYN-PF 10% is typically supplied via the major US wholesaler distribution network, since parenteral nutrition products are routinely handled by national distributors.

In practice, AMINOSYN-PF 10% procurement at scale usually goes through one of the following:

• McKesson
• Cardinal Health
• AmerisourceBergen / Cencora

These wholesalers distribute thousands of FDA-approved injectable products and are the default fulfillment route for hospital pharmacies when the product is in normal inventory.

Which contract distributors and GPO channels control AMINOSYN-PF 10% availability?

Answer: GPO contracting determines price, delivery terms, and inventory priority, even when the upstream manufacturer stays unchanged.

Key procurement pathways:

• GPO-negotiated contracts that tie hospitals to a preferred distributor
• Contract pharmacies that source via wholesaler networks
• Group purchasing arrangements used by IDNs and integrated delivery networks

How do shortages, discontinuations, or NDC changes affect suppliers of AMINOSYN-PF 10%?

Answer: Supplier availability changes when the labeler’s manufacturing slot, batch release, or NDC/package configuration changes.

For AMINOSYN-PF 10%, common operational triggers for supply interruption include:

• Manufacturing site disruptions
• Batch rejection and re-release timelines
• Packaging reconfiguration (container type, fill size)
• Short-lot production due to raw material constraints
• Market authorization changes (labeler transfer, NDC migration)

In those cases, downstream “suppliers” shift from full-stock distribution to limited allocations.

What generic or alternative amino acid suppliers compete with AMINOSYN-PF 10%?

Answer: Competitive supply usually comes from other FDA-approved amino acid injection products used for parenteral nutrition, not from “generic” AMINOSYN-PF 10% specifically unless an Abbreviated New Drug Application exists for the same reference product.

Competitive categories:

• Other 10% amino acid injection formulations for PN
• Combination PN products where amino acids are bundled with dextrose and electrolytes
• Ready-to-use PN bags from different manufacturers

What patent or regulatory status affects AMINOSYN-PF 10% suppliers?

Answer: Supplier entry and product continuity depend on the regulatory status of the reference amino acid injection and any exclusivities that apply to that specific FDA listing.

For amino acid injections, regulatory questions that can affect whether a new labeler can supply include:

• Whether the product is still under use or marketing exclusivity
• Whether there are listed patents tied to the active formulation, packaging, or manufacturing process
• Whether the product is withdrawn from the market or replaced with a different NDA/NDC package

How can procurement teams identify the correct AMINOSYN-PF 10% supplier at NDC level?

Answer: Procurement should validate the NDC, labeler/manufacturer, and package configuration before selecting a distributor.

Required validation steps (in practice):

• Confirm exact NDC for the product and package size
• Confirm labeler/manufacturer shown on the carton and product listing
• Confirm storage and handling requirements tied to that package configuration
• Confirm GMP lot traceability via distributor documents

What delivery and lead-time differences exist among AMINOSYN-PF 10% suppliers?

Answer: Delivery lead-time differences usually reflect distributor stock position, not different manufacturing.

Key drivers:

• Whether the product is held in local warehouse inventory
• Whether wholesalers can allocate stock during supply constraints
• Whether the distributor is sourcing from regional depots versus national central stock
• Whether the hospital contract specifies a specific distributor

Key Takeaways

• AMINOSYN-PF 10% suppliers split into upstream labeler/manufacturer (controls FDA-approved supply) and downstream wholesalers/distributors (fulfill to customers).
• In normal conditions, hospital access is typically routed through major national wholesalers such as McKesson, Cardinal Health, and Cencora.
• Supplier availability changes fastest at the NDC/labeler level when manufacturing, batch release, or package configurations change.
• Alternative product supply comes from other FDA-approved amino acid injections used for parenteral nutrition, and substitute selection is usually operational and formulary-driven.

FAQs

1) How do I find the exact manufacturer for AMINOSYN-PF 10%?

Use the product’s FDA label/SPL and confirm the labeler/manufacturer tied to the exact NDC.

2) Are AMINOSYN-PF 10% shortages caused by the manufacturer or wholesalers?

Shortages are usually upstream (manufacturing/batch release). Wholesalers reflect that by shifting allocation and lead times.

3) Can pharmacies substitute AMINOSYN-PF 10% with another amino acid injection?

Yes, substitution is possible if therapeutically interchangeable for the PN regimen and compliant with institutional policy and prescribing requirements.

4) Does AMINOSYN-PF 10% have multiple NDCs with different labelers?

It can. Package configuration changes or labeler transitions can create different NDCs that should be validated before ordering.

5) Who controls contract pricing for AMINOSYN-PF 10%?

Contract pricing is controlled by GPO and distributor contracting terms, even though the upstream manufacturer may remain the same.

References

1. FDA. Drug Label Information for AMINOSYN-PF 10%. US Food and Drug Administration.
2. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. US Food and Drug Administration.
3. FDA. NDC Directory. US Food and Drug Administration.