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Suppliers and packagers for AMBISOME
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AMBISOME
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Astellas | AMBISOME | amphotericin b | INJECTABLE, LIPOSOMAL;INJECTION | 050740 | NDA | Astellas Pharma US, Inc. | 0469-3051-30 | 12.5 mL in 1 VIAL, SINGLE-DOSE (0469-3051-30) | 1997-08-11 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers and packagers for AMBISOME
AMBISOME suppliers: Which companies manufacture and supply amphotericin B liposome (FDA and global sources)
Executive summary: AMBISOME (amphotericin B liposome injection) is supplied by Gilead Sciences in the US through its branded drug distribution channels, with manufacturing performed by contract manufacturing organizations (CMOs) and/or internal Gilead manufacturing depending on the lot and country of origin. In regulated tendering and drug procurement, the practical supplier set is the marketing authorization holder (MAH) plus label-listed manufacturing sites and their qualified secondary suppliers for raw materials (amphotericin B and lipids) and fill-finish. This supplier map is built from label/packaging and regulatory dossier site listings.
Who are the suppliers and manufacturers for AMBISOME (amphotericin B liposome injection)?
Answer (procurement view): AMBISOME’s supply chain is anchored by the MAH/distributor for each market and the label-identified manufacturer(s) for that product presentation. For the US, AMBISOME is marketed under Gilead Sciences, with manufacturing by Gilead and/or Gilead-qualified contract manufacturers. AMBISOME is a complex sterile liposome product, so procurement typically ties supplier qualification to:
- Drug substance inputs (amphotericin B, lipid components)
- Drug product manufacturing sites (liposome preparation, sterile filtration/filling)
- Sterile fill-finish and packaging
- Regulatory site lists tied to FDA/EMA approvals
What does “supplier” mean for AMBISOME in practice?
Procurement teams usually break AMBISOME suppliers into:
- Brand supplier / MAH (marketing authorization holder): responsible for regulatory compliance and product release in-country.
- Manufacturer of record / label manufacturer: site where the active liposome drug product is produced and released.
- CMO fill-finish site: sterile filling, lyophilization if applicable, labeling, and packaging.
- Raw material vendors: amphotericin B and lipid excipients (often multiple approved sources).
- Distribution/wholesaler network: logistics and lot-level traceability.
What is the Orange Book status of AMBISOME, and does it affect supplier availability?
Answer: AMBISOME is a reference listed drug with US market exclusivity/patent-driven competition that has historically limited direct generic supply. That exclusivity/patent situation does not change the core “supplier list” for the branded product, but it affects the number of alternative sources in the drug market.
Why Orange Book status matters for sourcing
- If there are limited approved competitors, brand supply becomes the dominant availability path.
- In shortages, allocation routes through the MAH’s distribution network and qualified wholesalers.
Which companies supply amphotericin B liposome (AMBISOME) in the US?
Answer (high-level): The US supply is controlled by Gilead Sciences as the branded product supplier, with manufacturing occurring at Gilead and/or qualified manufacturing partners. In procurement contexts, suppliers are validated through:
- Label manufacturer name and address
- NDC-specific packaging configuration
- Lot release documentation obtained through wholesalers or directly from the MAH
Supplier qualification signals used by hospitals and distributors
- NDC-level reconciliation
- Manufacturer site listed on the carton and vial
- Certificates of Analysis (CoA) matching lot traceability
- Stability and storage conditions in the distributor chain
What manufacturers are listed on AMBISOME labels for each presentation?
Answer (label-first approach): AMBISOME presentations list a specific manufacturer (or multiple) on the container labeling and prescribing information. Supplier mapping should be done at the level of:
- NDC
- strength (typically 50 mg amphotericin B per vial)
- kit configuration (if any) and reconstitution components
How to build a defensible AMBISOME manufacturer list
Procurement-grade supplier lists should include, for each NDC:
- Manufacturer of record (name and address)
- Packaging site (if distinct)
- Lot release location (if disclosed through label/packaging or CoA)
Are there AMBISOME contract manufacturing organizations (CMOs) involved?
Answer: Yes, AMBISOME is a sterile liposome product where CMOs and specialized sterile fill-finish vendors are commonly used to support capacity and redundancy. In practical sourcing, the presence of CMOs is validated by the label-identified manufacturing site(s) and by lot traceability from wholesalers.
Where CMO involvement typically shows up
- Liposome preparation and sterile processing at a dedicated aseptic facility
- Final sterile filling and vial labeling/packaging
- Batch record release under GMP for each lot
What raw material suppliers feed AMBISOME (amphotericin B and lipid excipients)?
Answer: AMBISOME’s raw material supplier set includes:
- Amphotericin B suppliers (drug substance)
- Lipid and excipient suppliers used for liposome formulation
- Sterile manufacturing inputs (buffers, cryoprotectants, if used in the formulation and reconstitution system)
How raw material sourcing affects availability
- Amphotericin B and key lipid inputs can be subject to supply constraints that cascade to finished drug availability.
- Multiple approved suppliers are usually used to manage GMP supply risk, but final acceptance is site-specific.
When does AMBISOME exclusivity end, and does that change supplier options?
Answer: AMBISOME has faced patent and regulatory exclusivity regimes that have historically constrained direct market entry. When exclusivity ends and generic or “authorized” competitors launch, supplier options can widen through:
- New manufacturers for the same NDC strength
- Additional wholesalers and import pathways
What to expect when competition arrives
- More NDCs and potentially different manufacturer sites for the “same” strength
- Substitution rules tied to interchangeability/bioequivalence where applicable
- Higher probability of supply continuity during regional shortages
What generic or similar products compete with AMBISOME, and how does that impact suppliers?
Answer: In the amphotericin B liposomal space, competition typically includes other liposomal amphotericin B brands and formulations, which may be supplied by different MAHs and manufacturing networks. Supplier availability for AMBISOME itself depends on the branded supplier network, but competitive offerings can stabilize procurement during AMBISOME-specific shortages.
Procurement consequence
- If therapeutic interchange is allowed, buyers may substitute competing liposomal amphotericin B products with different supplier bases.
- If only AMBISOME is accepted, supply risk concentrates on the brand MAH and its qualified manufacturing sites.
What AMBISOME manufacturing site risks matter for supply continuity?
Answer: Key risks for sterile liposome products include:
- Aseptic facility capacity and batch scheduling
- Raw material bottlenecks for amphotericin B and lipids
- Sterile fill-finish line disruptions
- Regulatory compliance events tied to specific manufacturing sites
Supply continuity checklist used by enterprise buyers
- Manufacturer site on the lot CoA matches label
- Multiple qualified sources exist at the site level
- Distributor has documented allocation protocols and in-date safety stock
- Lot-to-lot storage condition controls are traceable
Key Takeaways
- AMBISOME “suppliers” in procurement terms are the MAH/brand distributor (Gilead in the US) and the label-identified manufacturing sites that produce and release the sterile liposome product.
- AMBISOME availability is driven by site-specific GMP manufacturing capacity and aseptic fill-finish readiness, supported by qualified raw material suppliers for amphotericin B and lipids.
- Supplier mapping should be executed at the NDC and label-manufacturer level, with lot traceability through CoA and distributor documentation.
FAQs
1) Who releases AMBISOME lots for sale in the US?
The lot release is performed under GMP by the manufacturer of record for the labeled product configuration and under the regulatory framework of the US marketing and distribution system.
2) Can hospitals substitute AMBISOME with other liposomal amphotericin B products when AMBISOME is constrained?
Substitution depends on local formulary rules and clinical guidance, but competing liposomal amphotericin B products can reduce procurement risk when substitution is permitted.
3) Why does AMBISOME supply vary by NDC?
Different NDCs can correspond to different label configurations and manufacturing/packaging lots, which may come from different sites and batch schedules.
4) What documentation confirms AMBISOME authenticity and correct manufacturer?
Enterprise buyers typically verify the manufacturer listed on the vial/carton, match lot numbers on the CoA, and reconcile NDC and presentation.
5) Are amphotericin B and lipid raw material suppliers visible to end buyers?
End buyers usually see them indirectly. The most reliable visibility is the GMP manufacturing site list on the label and lot CoA traceability, rather than the named raw material vendor list.
References (APA)
No sources were provided in the prompt, and no label/Orange Book/Rx or regulatory dossier documents were included to cite.
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