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Suppliers and packagers for vidaza
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vidaza
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 | VIDAZA | azacitidine | POWDER;INTRAVENOUS, SUBCUTANEOUS | 050794 | NDA | Celgene Corporation | 59572-102-01 | 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 CARTON (59572-102-01) | 2004-07-05 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for Vidaza (azacitidine): manufacturers, fill-finish, and supply chain risks
Vidaza (azacitidine) supply is concentrated in a limited number of qualified commercial manufacturers plus specialized fill-finish and packaging vendors. The practical supplier universe for procurement is defined by FDA-validated manufacturing sites listed on the product’s labeling and current drug product supply chain coverage on the U.S. market.
Who supplies Vidaza (azacitidine) in the US commercial supply chain?
Answer: Vidaza’s supplier set is the labeled drug-substance and drug-product manufacturing sites plus the companies performing fill-finish, labeling/packaging, and distribution under FDA oversight.
Drug product manufacturing and fill-finish: what to verify in procurement
For Vidaza procurement and vendor onboarding, the supplier artifacts that govern interchangeability and quality are:
- FDA-approved drug product manufacturing site(s) listed on the label (site-specific releases)
- Fill-finish site(s) that actually container-load and carton configuration for the marketed presentation
- Packaging and labeling vendor(s) that produce NDC- and carton-specific configurations
- Quality agreements mapping cGMP controls from bulk to finished vials
Where supplier control usually sits for injectable oncology products
For injectable nucleoside analogs such as azacitidine, the supply chain bottlenecks typically cluster in:
- Aseptic fill-finish capacity and syringe/vial line changeovers
- Lyophilization or controlled drying steps (depending on dosage-form configuration used by the marketed presentation)
- Sterility assurance and container-closure integrity testing capacity
- Sterile component qualification (stoppers, seals, vials) and cold-chain logistics for finished product handling
What companies manufacture Vidaza (azacitidine) active ingredient and drug product?
Answer: The commercially active pharmaceutical ingredient and finished product supply for Vidaza is produced by the companies that hold the FDA-approved manufacturing responsibilities for azacitidine bulk and the finished sterile drug product, as reflected on the product’s FDA-approved labeling.
How supplier mapping is typically structured
Supplier mapping for Vidaza in a due-diligence packet usually distinguishes:
- API manufacturing vendor (azacitidine bulk)
- Drug product vendor (sterile finished azacitidine drug substance to final vial)
- Fill-finish vendor (aseptic processing and filling)
- Primary packaging vendor (vials, stoppers, crimp seals)
- Secondary packaging and labeling vendor (cartons, labeling, NDC printing)
Procurement-ready supplier evidence
Procurement-grade confirmation typically relies on:
- Batch release and CoA for specific lots
- FDA site identifiers (from label and/or FDA manufacturing listings)
- Quality agreement scope (sterile handling, aseptic process validation, deviations, CAPA response times)
Which contract manufacturers and fill-finish vendors handle azacitidine sterile injections?
Answer: Contract fill-finish vendors are limited to those qualified to run the relevant aseptic line processes for cytotoxic oncology injectables, with validated contamination control for hazardous drug products.
What “qualified” means for oncology injectables like azacitidine
A supplier considered qualified for Vidaza typically needs:
- Dedicated hazardous drug manufacturing zoning or validated decontamination controls
- Cytotoxic waste handling capability
- Environmental monitoring system coverage and sterility assurance alignment
- Cold-chain and shipment stability validation for the specific vial presentation
Risk flags in contracting
Common risks that affect supplier selection for injectables include:
- Cytotoxic production line capacity constraints
- Validation cadence delays when switching between compounds
- Increased deviation rates around changeovers in vials and stoppers
What does FDA labeling say about Vidaza manufacturing sites and suppliers?
Answer: Vidaza labeling identifies the responsible manufacturing sites for the drug product. Those sites are the authoritative reference for supplier qualification in the US market.
How to use label manufacturing statements for supplier onboarding
In supplier onboarding, procurement teams generally:
- Lock the supplier list to the label manufacturing site(s)
- Require that any outsourced steps occur within the labeled manufacturing approval framework
- Demand site-specific batch traceability for each lot purchased
How many suppliers can source Vidaza, and how concentrated is supply?
Answer: Vidaza supply is comparatively concentrated, with a small set of labeled commercial manufacturing responsibilities and limited fill-finish capacity appropriate for cytotoxic injectables.
Concentration drivers
Supply concentration is driven by:
- Complex aseptic controls for hazardous drugs
- Limited number of cGMP sites able to run azacitidine or closely related cytotoxic nucleoside analogs
- Regulatory and validation timelines for line qualification
What are the biggest supply bottlenecks for Vidaza?
Answer: The dominant constraints for Vidaza tend to be fill-finish line throughput, sterile processing capacity, and API-to-bulk-to-vial logistics under cGMP controls.
Typical bottleneck categories
- Aseptic manufacturing campaign capacity and scheduling downtime
- Sterile component availability (vial/closure systems)
- QA release timelines during high-demand periods
- Cold-chain shipment constraints and warehousing throughput
What supplier disruptions have affected Vidaza availability?
Answer: Vidaza availability has been affected by manufacturing capacity and quality system issues common to specialty injectables, reflected through FDA safety communications and shortage/availability notifications when they occur.
Procurement implication
For procurement planning, supply disruptions for specialty injectables should be treated as stochastic but correlated to:
- time to resolve deviations or batch rejects
- the number of concurrently qualified fill-finish lines
- seasonal demand swings in oncology centers
What is the supplier role in licensing and distribution of Vidaza?
Answer: The supplier manufacturing entity provides the drug product and API under cGMP and FDA-approved responsibilities. The distribution channel handles market access and fulfillment, often under branded commercial agreements.
How distribution interacts with supply
Procurement typically requires:
- allocation terms during constrained supply
- lot-level traceability through the distribution chain
- specification control for NDC-matched presentations
Key Takeaways
- Vidaza supplier mapping is anchored to the FDA-approved drug product manufacturing site(s) and associated fill-finish and packaging responsibilities shown on labeling and FDA manufacturing listings.
- The practical supplier set for procurement is small due to hazardous drug handling, aseptic validation requirements, and limited cytotoxic-capable contract manufacturing capacity.
- Supply risks concentrate in sterile fill-finish throughput, cytotoxic manufacturing zoning readiness, sterile component availability, and QA release timelines.
FAQs
-
How do I identify the correct Vidaza supplier for a specific NDC?
Use the NDC’s FDA-labeled manufacturing and packaging statements and require lot-level traceability for each purchased shipment. -
What contracts matter most for Vidaza supply continuity?
Quality agreement scope (cGMP controls across outsourced steps), allocation terms, and deviation/CAPA response SLAs. -
Can Vidaza be sourced from multiple fill-finish sites in the same quarter?
Only if those sites are within the FDA-approved manufacturing framework for the marketed presentation; confirm via lot traceability and label-aligned site coverage. -
What documentation should a Vidaza supplier provide during qualification?
CoAs, batch traceability, change control summaries for the manufacturing process and critical components, and evidence of sterile process validation controls. -
What supply chain controls should oncology distributors enforce for Vidaza?
Cold-chain stability compliance (where applicable), storage condition monitoring, NDC/carton integrity checks, and lot segregation to prevent cross-contamination errors.
References
- U.S. Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. FDA.
- U.S. Food and Drug Administration. Drug Shortages. FDA.
- FDA-approved labeling for Vidaza (azacitidine). U.S. Food and Drug Administration (access via DailyMed).
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