Last updated: May 23, 2026
PHYTONADIONE (vitamin K1; international nonproprietary name often listed as “phytonadione”) is supplied globally as an active pharmaceutical ingredient (API) and as finished products (oral drops, tablets, injectable forms). Supply chains typically run through a mix of China-India API manufacturers and regional finished-dose packagers, with distribution handled by specialty generics wholesalers and hospital distribution networks.
Who supplies phytonadione API and finished products globally?
Featured-snippet summary: Major phytonadione supply is concentrated in established vitamin/pharmaceutical intermediate producers supplying API, followed by dosage-form manufacturers and contract packaging for finished injectables and oral formulations.
API supplier landscape (typical buyer view)
Procurement of phytonadione API is usually executed via:
- API manufacturers (vitamin K1 API production and export)
- Distributor brokers/agents (sourcing from China/India and other low-cost supply hubs to regional buyers)
- Finished-dose manufacturers (who may source API internally or contract manufacturing)
Finished-dose supply channels
Finished phytonadione products are typically manufactured or packaged by:
- Generic injectables plants supplying hospitals and group purchasing organizations
- Oral solid/liquid manufacturers supplying retail and wholesaler networks
Common procurement partners buyers use
- API distributors with regulatory support packages (DMFs/ASMFs, COAs, stability, viral/BSE/TSE statements)
- Regional finished-dose wholesalers that can support tenders and urgent hospital replenishment
- CMOs for formulation/packaging (when brand holders outsource)
Which companies manufacture phytonadione injections and oral dosage forms?
Featured-snippet summary: Phytonadione finished products are supplied by generic and specialty drug makers covering injectable and oral forms, with hospital-focused manufacturers dominating injection supply.
Injection (phytonadione) supply considerations
Injectable phytonadione procurement often hinges on:
- Supplier’s ability to support sterility assurance, aseptic fill-finish (where applicable), and cold-chain requirements (if any for the specific product)
- Availability of traceable batch documentation for hospital QA
- Compliance history with compendial specifications (USP/EP grade alignment where applicable)
Oral forms supply considerations
Oral phytonadione procurement focuses on:
- Uniformity of dosing for drops and oral liquids
- Stability for solutions and suspensions (if the local product uses formulation systems that drive shelf-life)
What forms and strengths of phytonadione are most commonly sourced?
Featured-snippet summary: Buyers most commonly source phytonadione as vitamin K1 API and finished products in injectable and oral presentations.
Typical buyer-facing categories
- Phytonadione API: used for manufacturing injectables and oral formulations
- Injectable phytonadione: hospital and clinical use
- Oral phytonadione: outpatient and chronic-risk settings
How to evaluate phytonadione supplier qualification and quality systems?
Featured-snippet summary: Qualification is driven by regulatory documentation, quality agreement readiness, and batch reproducibility, not just price.
Qualification checklist used by pharmaceutical buyers
- Regulatory dossier support: DMF/ASMF availability for API; site licenses for finished products
- GxP manufacturing controls: validated cleaning, batch record integrity, deviation management
- Analytical controls: identity, assay, impurities, residual solvents, and physical characteristics depending on form
- Stability documentation: real-time and accelerated data aligned with the intended shelf-life
- Change control: supplier readiness to execute comparability assessments and provide protocol-ready documentation
What manufacturing/IP and regulatory barriers affect phytonadione supply?
Featured-snippet summary: Barriers are mainly regulatory and operational. Phytonadione supply is not typically blocked by complex IP in the way new molecular entities are, but quality and compliance are gating items.
Regulatory operational risks buyers screen
- Documentation completeness (COA, specs, impurity profile history)
- Plant inspection outcomes impacting approval status in target markets
- Batch-to-batch consistency and analytical method robustness
How does phytonadione supplier pricing typically vary by region and form?
Featured-snippet summary: Pricing varies primarily by form (API vs finished), regulatory tier, and whether supply is tender-driven (hospital) versus retail-driven (oral).
Pricing drivers
- API vs finished-dose value-add
- Regulatory compliance requirements in target markets
- Lead times for injectable lines and fill-finish slots
- Minimum order quantities and contract terms
What generic entry risks exist for phytonadione?
Featured-snippet summary: For phytonadione, entry risk tends to be less about patent exclusivity and more about the ability to supply compliant manufacturing and pass regulatory quality review.
Main entry risks
- Failure to meet specification/impurity profiles under local regulatory standards
- Delays from validation and stability confirmation for the chosen formulation
- Supply interruptions from capacity constraints in sterile manufacturing networks
Which suppliers are best positioned for hospital-grade phytonadione tenders?
Featured-snippet summary: Hospital tenders favor finished-dose manufacturers with established procurement coverage, reliable supply continuity, and ready hospital documentation.
Buyer-facing indicators
- Consistent in-stock performance
- Tender compliance: labeling, packaging size match, and logistics support
- Pharmacovigilance readiness and recall execution capabilities
How do you compare phytonadione API suppliers for procurement?
Featured-snippet summary: Compare on dossier readiness, impurity control, and manufacturing continuity. Price alone is not sufficient.
Comparison framework (actions buyers take)
- Request and compare API specs and impurity profiles
- Evaluate whether suppliers can provide stability data for the intended customer use-case
- Assess whether the supplier has a track record supplying the same strength/form factor to other pharma customers
Key Takeaways
- PHYTONADIONE supply is split between API producers and finished-dose manufacturers supplying injectable and oral forms.
- Procurement success depends on regulatory documentation readiness, quality system maturity, and batch consistency, especially for injectables.
- Supplier evaluation should prioritize spec alignment, impurity control, stability support, and delivery reliability for tender and hospital use.
FAQs
- What documentation does a buyer typically request when sourcing phytonadione API?
- How do injectable phytonadione supplier qualifications differ from oral form suppliers?
- What specs and impurity thresholds matter most for phytonadione API release?
- What lead-time and capacity constraints most affect phytonadione injectable supply?
- How should a manufacturer validate that phytonadione API from a new supplier is comparable?
References
- USP. USP–NF monographs and requirements for Vitamin K1 (phytonadione). United States Pharmacopeia.
- EMA. European Pharmacopoeia related standards for vitamin K1/phytonadione. European Directorate for the Quality of Medicines.
