Last updated: April 24, 2026
JANTOVEN is the brand name of warfarin sodium, an anticoagulant. In the US, warfarin sodium products have historically been supplied through a multi-manufacturer landscape spanning API (active pharmaceutical ingredient) production, tablet manufacturing, and secondary packaging and distribution. For business decisions, the actionable supplier set is the set of approved product manufacturers listed in regulatory submissions and labeling, plus the API manufacturers disclosed in drug master files (DMFs) and traced through FDA reviews and inspection records.
Because your request specifies only “Suppliers for JANTOVEN” without a geography, dosage strength, or time window, the only defensible supplier answer is the set of regulatory-anchored product manufacturers for warfarin sodium tablets marketed as JANTOVEN (brand holder and NDC-labeled manufacturers). Those are the suppliers that materially affect procurement, lead times, pharmacovigilance traceability, and quality alignment.
What suppliers does JANTOVEN use in the approved product chain?
1) Brand owner / label holder
JANTOVEN is marketed by Bristol Myers Squibb in the US (brand label owner). The label holder is the point of control for product-level distribution, pharmacovigilance, and regulatory commitments tied to the marketed product (labeling, lot reconciliation, and safety reporting).
2) Product manufacturing (tablet manufacture + packaging)
JANTOVEN is produced by contract manufacturing and packaging sites under approved marketing authorizations. In practice, the relevant supplier list for procurement equals:
- Tablet manufacturing site(s) for warfarin sodium tablets branded as JANTOVEN
- Secondary packaging site(s) (bottling/blistering and labeling) under the same approved product authorization
- Distribution channels tied to labeled NDCs (primary wholesaler/distributor network, then pharmacy fulfillment)
These “product-level” manufacturers are the ones that appear as the drug product manufacturer (and sometimes the packager) on labeling and regulatory listings for each NDC and strength.
3) API supplier (warfarin sodium)
Warfarin sodium APIs are typically sourced globally from a limited set of qualified API producers and/or DMF holders. API supplier identity impacts:
- raw material consistency (impurity profile and polymorphic behavior)
- change control and comparability packages
- audit readiness for GMP and data integrity
However, API supplier names are not consistently visible on public consumer-facing labeling. They are usually traceable via FDA drug approval packages, DMF references, and inspection assignments rather than the retail carton.
What should procurement treat as the “supplier list” for JANTOVEN?
For sourcing and vendor qualification, treat the supplier list as two tiers:
| Tier |
Supplier type |
What to capture |
Why it matters for decisions |
| Tier 1 |
Drug product manufacturers/packagers for branded JANTOVEN (by NDC and strength) |
Site name(s), role (manufacturer vs packager), GMP status, change history tied to that NDC |
Determines supply continuity, lead times, and lot traceability |
| Tier 2 |
API suppliers (warfarin sodium) referenced in approvals/DMFs |
DMF holder / referenced API manufacturer(s), update history, inspection outcomes |
Determines raw material quality risk and comparability during supply disruptions |
Which facts determine the correct supplier set by strength and NDC?
JANTOVEN is marketed in multiple tablet strengths, and different NDCs can map to different manufacturing and packaging sites. Supplier identification therefore must be anchored to the specific NDC(s) and the current label in force.
From a systems perspective, the reliable way to lock supplier identity is:
- Match the JANTOVEN strength and NDC
- Pull the current US label and FDA listing for that NDC
- Extract the labeled manufacturer/packager names
- Map those to current inspections and quality metrics (for vendor governance)
What’s the practical supplier roster you can act on now
Given the constraints of public visibility and the fact that “suppliers” vary by NDC and time, the only actionable roster that does not risk mislabeling is:
- Label owner / marketer: Bristol Myers Squibb
- Manufacturing & packaging sites: drug product manufacturers/packagers listed on the JANTOVEN label for each NDC and strength
- API suppliers: warfarin sodium API producers referenced via DMFs and approval packages for the branded product
This is the procurement-valid supplier taxonomy. Any attempt to name specific third-party sites without anchoring to the current NDC-labeled manufacturing/packaging entries risks producing a supplier list that does not match the lots you can actually source.
Supply-chain due diligence checklist (vendor qualification lens)
Use this checklist to operationalize “supplier selection” for JANTOVEN:
- NDC-based supplier mapping: lock manufacturing and packaging identities to each NDC/strength you buy
- GMP audit scope: confirm GMP status for the specific sites that made the lots you received
- Change control tracking: require advance notice of site changes, formulation/process changes, or API sourcing changes
- Lot traceability testing: ensure your QA can trace finished product lots back to manufacturing and packaging records
- API risk governance: for shortages or deviations, confirm API supplier changes are governed by comparability and documented impurity control
Key Takeaways
- JANTOVEN is warfarin sodium; supplier identity must be NDC and strength specific to be procurement-accurate.
- Treat the supplier set in two tiers: (1) drug product manufacturers/packagers for branded JANTOVEN and (2) warfarin sodium API suppliers referenced in approvals/DMFs.
- The only non-variant supplier that is stable across the brand is the US label holder/marketer: Bristol Myers Squibb; the manufacturing and packaging sites can vary by NDC.
FAQs
-
Is Bristol Myers Squibb the manufacturer of JANTOVEN tablets?
Bristol Myers Squibb is the US brand label holder/marketer; manufacturing and packaging can occur at contract sites shown on the product labeling by NDC.
-
Do JANTOVEN suppliers change by tablet strength?
Yes. Different NDCs and strengths can map to different manufacturing or packaging sites.
-
Can the warfarin sodium API supplier be confirmed from the carton label?
Usually not in a complete way. API supplier identity typically requires regulatory package or DMF traceability.
-
Why does NDC matter for supplier selection?
NDC ties you to the specific approved product presentation, including the labeled manufacturing/packaging sites and current supply chain configuration.
-
What is the fastest way to de-risk JANTOVEN sourcing?
Procure based on NDC-labeled manufacturer/packager identity and enforce lot traceability plus change-control notification from those sites.
References
[1] FDA. “Drug Label Information (DailyMed).” US Food and Drug Administration. https://dailymed.nlm.nih.gov/
[2] FDA. “NDC Directory.” US Food and Drug Administration. https://www.fda.gov/drugs/drug-approvals-and-databases/ndc-directory
[3] FDA. “Drug Master Files (DMFs).” US Food and Drug Administration. https://www.fda.gov/drugs/drug-master-files-dmfs
