Last updated: April 27, 2026
Who supplies Fragmin’s active ingredient (dalteparin sodium)?
Fragmin is dalteparin sodium, a low molecular weight heparin (LMWH) produced by enzymatic depolymerization of heparin derived from animal sources. For patent- and supply-chain due diligence, dalteparin sodium supply is typically concentrated in a small set of licensed manufacturers that sell either (a) the API under regulatory dossiers or (b) drug product via contract manufacturing.
API sourcing pattern (practical industry reality):
- Heparin-derived starting material suppliers: feedstock is extracted and purified heparin (most commonly from porcine intestinal mucosa).
- LMWH “conversion” manufacturers: perform the controlled depolymerization, fractionation, and characterization to meet LMWH specifications (including anti-factor Xa activity).
- Regulatory dossier holders / commercial API suppliers: package the API for downstream drug product manufacture.
However, a complete supplier list (by company name) cannot be stated here without verifiable, product-specific sourcing evidence (for example, regulatory filings that name the API manufacturer for dalteparin used in Fragmin, or credible public supply-chain disclosures for Fragmin drug product).
Who supplies Fragmin finished dosage forms (drug product)?
Fragmin is marketed as prefilled syringes and other presentations (strength varies by jurisdiction). Finished-dose manufacturing is typically performed by large sterile injectable CDMOs or in-house operations of the marketing authorization holder (MAH), depending on region.
A complete, accurate vendor roster for Fragmin finished dosage requires:
- country-by-country labeling/SmPC manufacturing sections that name the manufacturer(s) of the medicinal product, and
- market-specific packaging site information where applicable.
No region-specific manufacturing-site supplier list is provided here because it would require citing concrete labeling/regulatory text naming each manufacturer for each jurisdiction.
How to identify Fragmin suppliers from regulatory documents (what to look for)
For investment-grade sourcing, the supplier universe is extracted from two recurring places in regulatory and label artifacts:
1) SmPC / EPAR “Manufacturer of the finished product”
Look for lines naming the manufacturer responsible for production and quality release for the medicinal product.
2) Packaging/Release site
Look for packaging plants and quality-release sites where the label lists “Packaged by” or “Distributed by” and any additional manufacturing locations.
3) API manufacturing disclosure
Check for:
- API manufacturer name in the dossier summaries,
- GMP certificate holders,
- or cross-referenced API manufacturing sites named in the regulatory submissions.
Where Fragmin supply is commonly concentrated
Fragmin is an established LMWH with a mature supply chain. In such classes:
- the API is made by a limited number of LMWH-specialist manufacturers, and
- sterile fill-finish is performed by a smaller group of injectable sterile facilities under GMP.
That structure creates repeatable procurement outcomes: the number of credible suppliers for API and the number of credible suppliers for sterile drug product are both limited.
What due diligence requires for procurement or investment
A supplier screen for Fragmin should be anchored to evidence that maps directly to quality and regulatory compliance:
- GMP compliance scope for LMWH API and sterile fill-finish (as applicable).
- Batch release documentation availability history.
- Regulatory dossier linkage (who holds the manufacturing authorization for the API and/or finished product).
- Cold chain and storage compliance for the specific presentation.
- Anti-factor Xa assay and LMWH activity specifications alignment.
Key Takeaways
- A complete, named list of Fragmin suppliers cannot be produced from the information available here without jurisdiction-specific regulatory or labeling evidence that identifies API and finished-product manufacturers.
- Fragmin supply can be mapped using SmPC/EPAR sections that name the finished-product manufacturer and packaging sites, and dossier/GMP disclosures that name the dalteparin sodium API manufacturer.
- For actionable sourcing, procurement decisions should be based on documented manufacturer-of-record identities and GMP scope rather than inferred LMWH vendor networks.
FAQs
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What is the active ingredient in Fragmin?
Fragmin is dalteparin sodium, an LMWH.
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Do LMWH products like Fragmin share the same supplier base?
They often share a similar supply structure (heparin-derived feedstock, LMWH conversion, sterile fill-finish), but supplier identities vary by jurisdiction and regulatory dossier.
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Where do I find the manufacturer names for Fragmin in practice?
In each market’s SmPC/label sections that list “manufacturer of the medicinal product” and packaging/release sites.
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Can I identify the dalteparin (API) manufacturer from general LMWH supplier lists?
Not reliably. API manufacturer-of-record typically requires dossier or GMP/label evidence that explicitly names the API site.
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What quality parameters matter most for dalteparin supply?
LMWH activity specifications (anti-factor Xa), identity and purity parameters, and GMP-aligned batch release documentation.
References
[1] European Medicines Agency. EPAR for Fragmin (dalteparin).
[2] EMA product information (SmPC and related documents) for Fragmin across authorized presentations.
[3] FDA prescribing information (where applicable) and label manufacturing sections for Fragmin.
