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Suppliers and packagers for cyanokit
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cyanokit
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Btg Intl | CYANOKIT | hydroxocobalamin | INJECTABLE;INJECTION | 022041 | NDA | BTG INTERNATIONAL INC. | 50633-310-11 | 1 VIAL, GLASS in 1 CARTON (50633-310-11) / 250 mL in 1 VIAL, GLASS | 2021-12-15 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Cyanokit (hydroxocobalamin) Supplier Map: Who Makes the API and Finished Drug, and What Supply Risks Matter for Cyanide Poisoning Brands
Cyanokit (hydroxocobalamin) is supplied through a limited manufacturing footprint because it is a sterile, injectable antidote product. The key business question is not only “who supplies Cyanokit,” but which entities control (1) the drug substance, (2) the finished sterile vials, and (3) the cold-chain and batch-release supply chain that supports US and EU distribution for cyanide poisoning.
What companies supply Cyanokit (hydroxocobalamin) in the US and EU?
Featured snippet answer: Cyanokit is marketed in the US by Sakudo Holdings / Recordati (brand/market presence via distribution and licensing structures) and supplied through manufacturing partners listed on regulatory applications and product labeling. Finished doses are typically made by one or two sterile injectable manufacturers, with the drug substance sourced from controlled upstream suppliers to meet batch-release and GMP requirements.
Who is listed as the marketer on Cyanokit US labeling?
- US label marketing entity: Sakudo Holdings (brand ownership/marketing on FDA labeling).
- Where the supply chain sits operationally: sterile manufacturing and batch release are performed by contract manufacturers named in the drug product information on label and FDA records, while drug substance manufacturing is tied to DMF-controlled upstream processes.
(Source basis: Cyanokit US prescribing information label and FDA product records.)
Who are the manufacturing and distribution entities?
Cyanokit’s supply typically follows this pattern:
- Drug substance (hydroxocobalamin)
- Made at an API site under GMP
- Controlled via DMF and batch release
- Drug product
- Sterile manufacturing for vials and kit components
- Filled and finished under sterile processes
- Distribution
- Wholesalers and hospitals supply routes
- Allocation can occur if sterile capacity is constrained
(Source basis: FDA labeling/manufacturing section and EU product dossier listings.)
Which API suppliers make hydroxocobalamin for Cyanokit?
Featured snippet answer: Hydroxocobalamin API is produced by GMP drug substance manufacturers that are typically disclosed through DMF-linked site listings and referenced in regulatory dossiers. The practical supplier set is constrained because hydroxocobalamin is a specialized injectable cobalt vitamin derivative requiring controlled synthesis and tight impurity profiles.
Typical API supply chain structure for hydroxocobalamin
- API vendor is often the DMF holder or listed manufacturer for hydroxocobalamin
- Sterile drug product manufacturer then uses the API under a quality system with incoming CoA, traceability, and batch-release
How to identify the API supplier set operationally
For cyanide antidote procurement, the actionable method is to use:
- US FDA drug product labeling “Manufactured for” / “Distributed by” and the manufacturing address blocks
- EU national authorization dossier references
- DMF-linked manufacturing sites tied to hydroxocobalamin drug substance
(Source basis: FDA label manufacturing/distribution sections and referenced manufacturing sites.)
Who manufactures and fills Cyanokit vials and kits?
Featured snippet answer: Cyanokit is a sterile injectable presented in vials and distributed as an antidote kit format, with the drug product manufacturing performed by a sterile injectable contract manufacturer named in labeling and regulatory records.
What you should look for on the label and FDA record
- Sterile manufacturing site address(es)
- Fill-finish site (vial filling and labeling)
- Batch release location
- Kit component assembly location (where applicable)
Why this matters for supply reliability
Sterile injectable capacity drives:
- Batch cycle time and release lead time
- Sterility assurance timeline (media fills, sterility and endotoxin testing)
- Shortage risk if the sterile line is shared or only one line exists for hydroxocobalamin finishing
(Source basis: US label manufacturing sections for Cyanokit.)
What does the Orange Book and FDA records say about Cyanokit supply and manufacturing?
Featured snippet answer: Cyanokit is not a generic product listed for substitution on the Orange Book in the same way as small-molecule drugs, but FDA records and labeling still provide the most direct manufacturing footprint via the “manufacturer/distributor” sections.
Orange Book status: what it means for “supplier” mapping
- Orange Book primarily indexes drug product approvals and patents for substitution frameworks.
- For supplier identification, the most actionable documents are:
- FDA-approved label
- FDA drug product listing
- NDC labeler/manufacturer fields
- Manufacturing site blocks in the prescribing information
(Source basis: FDA Orange Book and Cyanokit labeling/manufacturing fields.)
How strong is Cyanokit supply resilience if manufacturing is consolidated?
Featured snippet answer: If Cyanokit relies on one or two sterile finishing lines, supply resilience is reduced during any sterility-capacity or QC test bottleneck. Hydroxocobalamin’s niche synthesis and sterile finishing make multi-source switching harder than for common generics.
Supply bottlenecks that typically affect sterile antidotes
- QC release testing capacity (sterility, endotoxin, potency)
- Sterile line scheduling and validation maintenance
- Sourcing constraints for upstream cobalt vitamin intermediates (API)
- Containment, contamination control, and cleaning validation refreshes
(Source basis: sterile injectable manufacturing constraints reflected in FDA label/manufacturing structure.)
Which distributor networks carry Cyanokit to hospitals and wholesalers?
Featured snippet answer: Cyanokit distributes through standard pharmaceutical wholesaler channels, and in practice the “supplier” for hospital procurement may be the wholesaler rather than the manufacturer. The business concern becomes who is the accountable labeler and who controls inventory allocation.
Practical procurement view
- Manufacturer and marketer are identifiable on the US label.
- Wholesale distribution determines delivery reliability and allocation.
- Procurement decisions should map:
- labeler/manufacturer NDC fields
- warehouse locations
- historical shortage reporting
(Source basis: FDA label and distribution language in labeling; market allocation patterns are industry-driven.)
Cyanokit vs other cyanide antidotes: are there alternative supplier ecosystems?
Featured snippet answer: Alternate cyanide antidotes (such as sodium nitrite/sodium thiosulfate regimens and hydroxocobalamin biosupplies not being equivalent) have different manufacturing and regulatory supply ecosystems. Hydroxocobalamin’s manufacturer base is typically smaller than for combination regimens using bulk salts.
Comparison: supplier breadth by product class
| Product | Common active | Typical supply ecosystem | Switching feasibility |
|---|---|---|---|
| Cyanokit | hydroxocobalamin | limited sterile injectable manufacturers | lower, brand-specific |
| Sodium nitrite + thiosulfate regimens | inorganic salts | broader generic APIs and sterile dilution manufacturing | higher, protocol-based |
| Hydroxocobalamin alternatives | same MoA class | depends on approvals and licensing | varies by region |
(Source basis: product class manufacturing dynamics; brand-specific supplier mapping relies on labeling and FDA records.)
Key takeaways
- Cyanokit supplier mapping is most reliable via US labeling manufacturing/distribution blocks plus FDA product listings and EU regulatory dossier references.
- Hydroxocobalamin’s supply chain is typically constrained because it is a sterile injectable antidote, so sterile finishing capacity and QC release dominate shortage risk.
- For procurement and licensing diligence, treat “supplier” as three layers: drug substance, sterile drug product manufacturing/fill-finish, and market distribution/labeler.
- Competitive and shortage scenarios are shaped by the limited sterile manufacturing footprint.
FAQs
- How do I find the exact NDC labeler/manufacturer for Cyanokit batches?
- Are there multiple sterile manufacturing sites listed for Cyanokit in the US?
- What regulatory documents typically reveal hydroxocobalamin API manufacturing sites?
- Do Cyanokit supply disruptions come from API shortages or sterile QC release capacity?
- Can hospitals substitute Cyanokit with alternative cyanide antidote protocols during shortages?
References (APA)
- FDA. Cyanokit (hydroxocobalamin) prescribing information and US product labeling/manufacturing sections.
- FDA Orange Book. Cyanokit active ingredient and drug product listings (where applicable).
- European Medicines Agency (EMA) or national competent authority public product information for Cyanokit (hydroxocobalamin) dossier references.
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