Suppliers and packagers for abraxane

abraxane

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Bristol-myers	ABRAXANE	paclitaxel	POWDER;INTRAVENOUS	021660	NDA	Abraxis BioScience, LLC	68817-134-50	1 VIAL, SINGLE-USE in 1 CARTON (68817-134-50) / 20 mL in 1 VIAL, SINGLE-USE	2005-02-10

Suppliers and packagers for abraxane

Last updated: May 31, 2026

Abraxane suppliers: key manufacturers, contract manufacturers, and raw-material sources for paclitaxel albumin-stabilized nanoparticles (nab-paclitaxel)

Abraxane (paclitaxel protein-bound particles for injectable suspension, nab-paclitaxel) is supplied through a defined upstream chain centered on Celgene (now Bristol Myers Squibb) ownership of the product, with production carried out by specialized sterile-injectables and nanoparticle manufacturing capabilities. Upstream supply inputs include paclitaxel drug substance, albumin (human), and sterile manufacturing components (single-use and controlled drug substance handling). The practical supplier set for operations and procurement is typically split across (1) drug substance (paclitaxel), (2) albumin supply and purification, (3) sterile fill-finish and nanoparticle formulation, and (4) packaging and distribution.

Abraxane supplier landscape (procurement-relevant)

• Product owner/marketer: Bristol Myers Squibb (BMS) (licensed/marketed Abraxane in the US).
• Active ingredient (paclitaxel) supply: sourced from established paclitaxel API manufacturers used in global oncology supply chains.
• Albumin supply: human albumin sourced under pharmaceutical-grade controls and processed/purified for injectable use.
• Nanoparticle formulation and sterile manufacturing: typically performed at GMP sterile injectables sites with capability for albumin nanoparticle production and aseptic processing.
• Packaging and distribution: specialized pharma packaging and cold-chain handling (where required by product handling specs).

Who supplies Abraxane (paclitaxel albumin-stabilized nanoparticles) to US wholesalers?

Abraxane’s commercial supply in the US is managed by the product owner (BMS) through GMP manufacturing partners and third-party logistics aligned to sterile injectable distribution controls. In practice, “supplier” in procurement terms means the GMP site(s) on the product’s manufacturing label and the licensed establishments that appear in regulatory submissions and labeling.

What to treat as “supplier” in operations

• Label-listed manufacturing site(s): the operative GMP supplier(s) for aseptic drug product manufacturing.
• Nab-paclitaxel manufacturing capability: formulation of albumin-stabilized paclitaxel nanoparticles under cGMP, with validated particle and stability specifications.
• Fill-finish sterile controls: aseptic processing, filtration, container closure integrity, and sterile inspection controls.
• Component suppliers: human albumin source chain and sterile packaging components.

Which companies manufacture the drug product Abraxane under contract manufacturing agreements (CMOs)?

Abraxane is produced at GMP facilities that handle sterile injectables and nanoparticle drug product. The contract/partner manufacturing question is answered in practice by the FDA label (US prescribing information) manufacturing section and the FDA establishment listings linked to the product.

Procurement-relevant CMO categories

• Nanoparticle formulation (nab-paclitaxel): GMP site with validated nanoparticle process and albumin handling.
• Aseptic fill-finish: sterile filling into final containers with validated aseptic processing and environmental monitoring.
• Quality release testing: LC/particle size distribution/encapsulation profile and sterility release.

Who supplies the paclitaxel drug substance used for Abraxane?

Paclitaxel is a complex oncology API with constrained supply and a limited set of global producers at pharmaceutical GMP standard. For nab-paclitaxel, API sourcing must support:

• consistent impurity profile,
• defined drug substance quality for encapsulation into albumin nanoparticles,
• stable lot acceptance for downstream nanoparticle manufacturing.

Drug-substance supplier profile (what procurement requires)

• GMP paclitaxel API production with validated analytical methods.
• Supply chain controls for solvent handling, residuals, and impurity specifications.
• Lot traceability supporting drug product release.

Which suppliers provide human albumin for Abraxane nanoparticle formulation?

Abraxane contains human albumin as the protein-bound carrier for paclitaxel nanoparticles. Albumin supply must align with injectable-grade specifications and sourcing controls that support:

• viral safety and impurity controls,
• batch consistency for nanoparticle formation,
• compatibility with nab-paclitaxel process parameters.

Albumin sourcing and quality checkpoints

• Source material controls and purification steps that deliver injectable-grade albumin.
• GMP documentation linking albumin lot quality to downstream nanoparticle release specifications.

What raw materials and components are required for Abraxane manufacturing?

Beyond paclitaxel and human albumin, sterile injectable manufacturing uses defined component and process inputs that typically include:

• sterile filtration systems,
• sterile disposable tubing and single-use vessels,
• container closure system components (vials, stoppers, seals),
• nitrogen/controlled atmosphere supplies where applicable,
• validated cleaning and sterilization agents consistent with sterile injectable GMP.

Manufacturing input categories | Input category | Procurement relevance | Typical control focus | |---|---|---| | Paclitaxel API | Major cost and capacity driver | impurity profile, polymorph, assay stability | | Human albumin | Major batch consistency driver | viral safety, grade, lot-to-lot acceptance | | Sterile injectables consumables | Operational continuity risk | extractables/leachables, compatibility | | Final packaging | Distribution and handling risk | container closure integrity, label/UDI specs | | QC release reagents | Testing continuity | method validation, stability of reference standards |

How can suppliers verify they are eligible to support Abraxane production (GMP and regulatory checks)?

Eligibility for Abraxane-related supply roles is governed by cGMP capability and quality systems that satisfy regulatory expectations for sterile injectables and complex nanoparticle formulations.

Supplier qualification expectations

• GMP manufacturing and quality release system.
• Change control discipline for formulation/process parameters.
• Analytical method robustness for nanoparticle critical quality attributes (for drug product related parties).

What is the FDA manufacturing and establishment information for Abraxane (Orange Book and label linkage)?

Abraxane is a branded oncology product with FDA regulatory documentation that links:

• NDA labeling (manufacturing section listing),
• drug product regulatory info in the FDA system,
• establishment details for manufacturing and testing roles.

How to use FDA data for supplier mapping

1. Pull the product labeling’s manufacturing section to identify the drug product manufacturing site(s).
2. Link those site(s) to FDA establishment registrations to confirm active manufacturing and testing roles.
3. Use application supplements to capture changes in manufacturing networks over time.

How does Abraxane supply vary by formulation strength and dosage form (risk to upstream suppliers)?

Abraxane is supplied as a sterile injectable suspension in vial strengths (commonly referenced in oncology procurement by mg per vial). Supply risk concentrates in:

• nanoparticle formulation capacity for each strength,
• vial/stopper supply for the specific vial format,
• QC testing bottlenecks for sterility and product quality attributes.

Supplier impact points

• If a fill-finish line is constrained, the upstream nanoparticle process becomes inventory-bound.
• If packaging component lead times extend, drug product release and distribution schedules shift.

What suppliers are used for cold-chain or temperature-controlled distribution of Abraxane?

Temperature-controlled distribution depends on product handling instructions in the labeling and logistics chain design. Procurement suppliers for distribution generally include:

• third-party logistics providers with validated temperature monitoring,
• wholesalers/distribution centers with handling SOPs that match label conditions.

Distribution supplier selection criteria

• validated monitoring,
• chain-of-custody controls,
• audit-ready documentation for sterile oncology handling.

Supplier concentration risk: where do delays most often originate for Abraxane?

Supply chain fragility typically arises in three places:

• paclitaxel API capacity and lot acceptance for impurity profile,
• human albumin availability and grade batch consistency,
• fill-finish packaging component lead times and sterile line scheduling.

Risk pattern for procurement planning

• API constraints tend to create long lead times.
• Albumin supply constraints create batch re-qualification needs.
• Fill-finish and vial component delays create immediate release schedule pressure.

Which competitors use similar supply networks (nab-paclitaxel and albumin-bound oncology injectables) and how do supplier networks compare?

Other albumin-bound taxane or nanoparticle oncology products do not map 1:1 to Abraxane’s exact supply chain but share upstream categories:

• taxane API sourcing,
• albumin carrier processing,
• sterile injectables fill-finish.

Competitive supplier similarity (categories)

• paclitaxel-like APIs and related impurity controls,
• sterile injectable CMO networks,
• human albumin injectable-grade supply chains.

Key Takeaways

• “Abraxane suppliers” in procurement terms are best mapped through label-listed manufacturing sites and linked FDA establishment registrations, then extended upstream to paclitaxel API suppliers and human albumin supply.
• Upstream constraints concentrate in paclitaxel API, injectable-grade human albumin, and sterile nanoparticle fill-finish capacity.
• Packaging component lead times and QC release testing capacity can materially shift distribution schedules even when nanoparticle formulation capacity is available.

FAQs

1) How do I identify the actual manufacturer(s) of Abraxane drug product?
Use the US Abraxane label manufacturing section to identify the listed manufacturing site(s), then cross-check those sites in FDA establishment listings.

2) Are there multiple suppliers for paclitaxel API used in Abraxane?
Typically yes in global pharma supply chains, but the operative supplier set is determined by BMS qualified supplier networks and drug product release acceptance per lot.

3) What role does human albumin supply play in Abraxane production continuity?
Albumin lot acceptance and consistency are required for nanoparticle formation and product quality release, making injectable-grade albumin a key continuity risk.

4) Which parts of the Abraxane supply chain are most sensitive to shortages?
Paclitaxel API supply, injectable-grade albumin availability, and sterile fill-finish line and vial component continuity.

5) Do temperature-controlled logistics materially affect Abraxane distribution?
Distribution temperature requirements are label-driven; temperature-controlled logistics and monitoring are standard for sterile oncology products with specified handling conditions.

References

1. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. (Abraxane listings). U.S. Food and Drug Administration.
2. FDA. Drugs@FDA. Abraxane (nab-paclitaxel) NDA/regulatory information and label. U.S. Food and Drug Administration.
3. FDA. SPL/Prescribing Information for Abraxane (paclitaxel protein-bound particles for injectable suspension). U.S. Food and Drug Administration.
4. FDA. National Drug Code (NDC) and product labeling resources tied to Abraxane. U.S. Food and Drug Administration.