Suppliers and packagers for INTRALIPID 10%

INTRALIPID 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
Fresenius	INTRALIPID 10%	soybean oil	INJECTABLE;INJECTION	017643	NDA	Baxter Healthcare CORP	0338-0518-12	250 mL in 1 BAG (0338-0518-12)	2014-12-12
Fresenius	INTRALIPID 10%	soybean oil	INJECTABLE;INJECTION	017643	NDA	Baxter Healthcare CORP	0338-0518-13	500 mL in 1 BAG (0338-0518-13)	2014-12-12
Fresenius	INTRALIPID 10%	soybean oil	INJECTABLE;INJECTION	017643	NDA	Baxter Healthcare CORP	0338-0518-58	100 mL in 1 BAG (0338-0518-58)	2014-12-12

Suppliers and packagers for INTRALIPID 10%

Last updated: June 9, 2026

INTRALIPID 10% suppliers: Who manufactures and distributes the 10% IV lipid emulsion (and what to check for sourcing)

Executive summary: INTRALIPID 10% (IV fat emulsion) is supplied in the US and other markets through multiple channels. Common sourcing paths are (1) the brand manufacturer/marketing authorization holder and its distribution network, (2) listed distributors and wholesalers tied to the US labeler/marketing chain, and (3) hospital group purchasing organizations (GPOs) that contract directly with the authorized supply chain. For compliant procurement, the core checks are the exact strength (“10%”), dosage form (IV lipid emulsion), NDC/labeler, and whether the product is for the US market or another region’s equivalent.

Who supplies INTRALIPID 10% in the US?

Answer: INTRALIPID 10% supply in the US runs through the product’s branded marketing chain (labeler/holder) and authorized wholesalers/distributors that list the product under its NDC. Procurement teams typically buy via GPO contracted distributors or standard hospital wholesaler accounts.

Which entity is the “labeler” behind INTRALIPID 10%?

Featured-supplier procurement should start with the US NDC listing, because the NDC ties to the US labeler, package configuration, and the “ship-to” market version. Without the specific NDC and package size, the definitive “who supplies” mapping cannot be stated precisely.

What distribution channels are used for INTRALIPID 10%?

Common, compliant channels include:

• Authorized wholesalers/distributors listed in commercial ordering systems under the product’s NDC.
• GPO contracts (hospital pharmacy and supply chain purchasing) that route orders through contracted distributors.
• Direct-to-hospital ordering only when the labeler’s distribution model supports it.

What distributors sell INTRALIPID 10% to hospitals and wholesalers?

Answer: Distributors typically sell INTRALIPID 10% as an NDC-tracked product through hospital and alternate-site procurement accounts. Distributor identity depends on the exact NDC and distribution region.

What procurement teams should verify before PO placement

• NDC match for strength and package size (10% IV lipid emulsion).
• US-market label versus imported equivalent.
• Lot traceability fields in the distributor’s invoice pack list (lot, exp, and manufacturer/labeler details).
• Storage/handling requirements aligned to IV lipid emulsion stability and container handling.

Does INTRALIPID 10% have multiple manufacturers or just one?

Answer: INTRALIPID is an IV lipid emulsion brand whose supply can involve multiple packaging/labeling configurations and potentially different contract manufacturing or packaging sites across regions, depending on regulatory status and market authorization. For a correct “which manufacturer” answer, the NDC or the target country’s authorization dossier must be identified.

How to distinguish manufacturer vs. marketer vs. packager

• Marketing authorization holder / labeler: listed on US carton and FDA labeling context.
• Manufacturer of record / site: on the label or regulatory listing.
• Packager/distributor: sometimes separate from manufacturing, especially in global supply chains.

Who are the alternative suppliers (generic or equivalent IV lipid emulsions) if INTRALIPID 10% is constrained?

Answer: When INTRALIPID 10% supply is constrained, hospitals usually pivot to equivalent IV lipid emulsion products with the same therapeutic class and comparable administration intent (parenteral nutrition lipid source). The safe substitution decision depends on:

• exact lipid composition and dosing equivalence,
• container type and pharmacy mixing compatibility (if applicable),
• allergy risk profiles (egg/soy components can differ by product line),
• and compatibility with co-administered PN components.

What to compare for an equivalent substitution

• Lipid strength (must be 10% if targeting that dose density).
• Per mL lipid formulation components (soybean oil, egg phospholipids, glycerin, etc., depending on product).
• Container system (single vs multi-dose bag, pharmacy draw vs bag use).
• Compatibility and infusion set guidance on label and package insert.

What is the Orange Book status of INTRALIPID 10% and how does it affect sourcing?

Answer: INTRALIPID 10% is a branded IV drug product with labeling and potential generic equivalents in the US supply ecosystem, but Orange Book exclusivity or patent status does not directly determine day-to-day supplier identity. In practice, sourcing is driven by:

• whether the same exact NDC is available from the brand supply chain,
• whether therapeutically equivalent products are on-contract,
• and substitution policies and pharmacy formularies.

Why Orange Book details matter for supplier risk

• If there are fewer direct equivalents, supplier constraints can be acute.
• If multiple equivalent NDCs exist, procurement leverage increases through therapeutic substitution options.

What generic entry risks exist for INTRALIPID 10%?

Answer: “Generic entry risk” for an established IV lipid emulsion can affect long-term supply competition, but it does not map cleanly to “who supplies today” without the exact US product identifiers and regulatory history for that NDC.

Procurement impact

• Greater generic or alternative availability reduces single-source risk.
• Limited alternatives increase price and allocation sensitivity during manufacturing disruptions.

When do INTRALIPID 10% supply allocations or shortages typically occur (and what causes them)?

Answer: Supply disruptions for IV lipid emulsions can occur due to:

• raw material constraints for lipid components and phospholipids,
• container and sterile manufacturing capacity limits,
• quality system holds or stability/labeling-related issues,
• seasonal demand shifts for parenteral nutrition.

Operational mitigations procurement teams use

• Multiple distributor sourcing where allowed by contract.
• Blanket POs with different distributor warehouses (ship-to flexibility).
• Formulary-approved therapeutic equivalents with pharmacy guidance.

Which countries supply INTRALIPID 10% and how do they differ?

Answer: Global supply often diverges by authorization market. “INTRALIPID 10%” may exist as the same brand with region-specific packaging sizes, label language, and NDC-equivalent identifiers. Procurement must match the intended market label.

Regulatory naming differences to watch

• Strength and percent units can be presented consistently, but container volumes and labeling may differ.
• Alternate equivalents can use different brand names even when composition is similar.

---

Key Takeaways

• INTRALIPID 10% sourcing is NDC-driven in the US and tied to the labeler’s authorized distribution chain.
• “Who supplies” depends on the exact NDC (strength plus pack size) and the market (US vs international).
• When supply is constrained, hospitals usually switch to formulary-approved 10% IV lipid emulsions with comparable lipid composition and compatible container systems.
• Orange Book status is less relevant to immediate supplier identity than it is to long-term availability competition and substitution pathways.

FAQs

1. How do I identify the correct INTRALIPID 10% product for procurement if I only have the name?
2. What NDC fields should buyers capture to ensure lot traceability for INTRALIPID 10%?
3. What are the key formulation/composition differences to check when substituting another 10% IV lipid emulsion for INTRALIPID?
4. How do GPO contracts typically affect which distributors carry INTRALIPID 10%?
5. What documentation should hospitals require from distributors during shortages for INTRALIPID 10%?

References

1. (No citations provided because the prompt does not include a specific country/NDC or labeling identifiers, and the response must avoid producing unverifiable supplier claims.)