Last updated: April 29, 2026
Who supplies Leucovorin Calcium, preservative-free?
Leucovorin Calcium preservative-free is supplied as a parenteral product (typically for IV use) in single-dose vials or ampules. The supplier universe is defined by (i) US-market label holders/manufacturers for the preservative-free presentations and (ii) contract manufacturers that produce preservative-free sterile leucovorin formulations for branded and private-label distribution.
Which companies supply Leucovorin Calcium preservative-free in the US?
No verifiable supplier list is available in the provided inputs. A complete and accurate supplier map requires current label/ANDA/BLA source data, NDC-to-manufacturer linkages, and manufacturer-of-record for the specific “preservative-free” presentations. That information is not present in the material you provided, so producing a supplier roster would risk incorrect attribution.
What sourcing is typical for preservative-free sterile leucovorin?
In the US, “preservative-free” sterile injectables generally require:
- Sterile drug product manufacturing under current Good Manufacturing Practice (cGMP)
- Aseptic filling and terminal sterilization strategy aligned to formulation and container closure
- Container closure integrity for single-dose vials/ampules (often low bioburden and controlled hold times)
- Quality system documentation that explicitly supports the “preservative-free” claim on the label
This structure means supply can shift through:
- Market authorization holder changes (labeling/manufacturer of record updates)
- Site changes (contract manufacturing relocation)
- Temporary allocation during supply disruptions
How to interpret “supplier” in procurement and contracting
For procurement and patent/strategic sourcing work, “supplier” can mean one of three distinct entities:
- Label holder / Market authorization holder (US market responsibility)
- Manufacturer of record (site that releases the product)
- Contract manufacturer (sterile drug product manufacturer, sometimes not visible on the outer packaging)
A defensible supplier list must map all three to the specific preservative-free NDC presentation.
Key Takeaways
- A complete, accurate supplier roster for Leucovorin Calcium preservative-free cannot be produced from the information available here.
- For decision-grade sourcing, “supplier” must be mapped to the preservative-free presentation’s NDC and linked to manufacturer of record plus the label holder.
FAQs
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What does “preservative-free” mean for leucovorin calcium injectable products?
It means the formulation contains no antimicrobial preservative, typically requiring preservative-free labeling and matching aseptic processing controls.
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Is the supplier the same as the label holder?
Not always. The label holder and the manufacturer of record can differ, especially with contract sterile manufacturing.
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Why does the supplier list change over time?
It changes with site transfers, label updates, contract manufacturing shifts, and allocation during shortages.
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How do I ensure I’m sourcing the preservative-free version, not the standard version?
By matching the exact preservative-free NDC presentation to the manufacturer of record.
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Can distributors be treated as “suppliers” for sourcing or IP analysis?
Usually not for IP or manufacturing sourcing. Distributor roles differ from manufacturer of record and are not the production source for patent attribution.
References
[1] U.S. Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. FDA. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm (accessed 2026-04-29)
[2] DailyMed. Leucovorin Calcium injection, preservative-free label information. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/ (accessed 2026-04-29)
