Last updated: May 27, 2026
What companies supply dalteparin sodium (Fragmin) in the US and EU?
Dalteparin sodium supply is historically linked to the originator and its manufacturing network, with regional secondary sourcing driven by regulatory approvals, label/strength-specific manufacturing, and sterile filling capacity.
US supply structure: branded chain vs. manufacturing network
In the US, dalteparin sodium is commercialized under the brand Fragmin, and distribution typically moves through the branded holder’s logistics channels, with API and finished-dose manufacturing performed by designated manufacturing sites. For supplier mapping, the key diligence targets are:
- The approved drug substance (dalteparin sodium) manufacturing site(s)
- The finished drug product manufacturing and sterile filling site(s) for each strength/packaging
- Any authorized manufacturing changes recorded in FDA submissions and label history
EU supply structure: marketing authorization holder sites and batch certification
In the EU, supplier identification is most accurate through:
- Marketing authorization holder (MAH) manufacturing site listings
- Batch release/certification sites (QPs) and manufacturing locations listed for each strength
- Transfer or variation history that changes which plants produce which presentations
Who manufactures dalteparin sodium API (drug substance) and how is LMWH sourced?
Dalteparin sodium is an LMWH made by chemical or enzymatic depolymerization and controlled fractionation of heparin, followed by purification steps to achieve target molecular weight distribution.
Primary upstream dependency: porcine heparin and depolymerization control
The supply constraint is not only “manufacturing capacity,” but input heparin sourcing and reproducible depolymerization. Downstream drug substance lots require consistent:
- Starting heparin quality and traceability
- Depolymerization parameters (process controls)
- Fractionation/purification and molecular weight distribution targets
API supplier archetype
Supplier categories that appear in dalteparin sodium sourcing:
- Heparin upstream refiners and depolymerization specialists that produce LMWH intermediates
- API manufacturers that finish purification to a dalteparin sodium specification
- Sites that can support compliance for sterile injectable anticoagulant production (even if aseptic filling is separate)
Which contract manufacturing organizations (CMOs) produce dalteparin sodium prefilled syringes?
Dalteparin sodium is typically supplied as sterile injectable presentations such as prefilled syringes and, in some markets, vials or other pack formats. For procurement, the practical “supplier” is the facility that:
- Conducts sterile filtration and aseptic processing
- Fills and seals prefilled syringes
- Performs terminal sterilization or validated sterilization method per approved process
- Packages under controlled conditions to anticoagulant specifications
What to verify when selecting syringe-filling supply
When mapping or qualifying a CMO/sterile fill supplier for dalteparin sodium, diligence focuses on:
- Aseptic filling lines and relevant sterile injectable approvals
- Cleaning validation for anticoagulants to manage cross-contamination risk
- Facility approvals for heparin-derived products
- Batch record and deviation history for sterile anticoagulants
What suppliers deliver dalteparin sodium to hospitals, wholesalers, and distributors?
Direct hospital supply is commonly routed through major pharmaceutical wholesalers and specialty distributors. The “supplier list” for actual procurement is often the distribution network rather than the plant-level manufacturing. For business planning, the key operational suppliers are:
- Wholesalers that maintain Fragmin inventory and replenish based on allocation
- Specialty anticoagulant distribution channels
- Authorized distributors tied to the MAH/brand holder
Procurement risk points
Procurement fragility typically arises from:
- Batch releases tied to specific manufacturing sites
- Regulatory variations that prevent substitution across presentations
- Sterile filling capacity constraints and seasonal heparin supply volatility
How many dalteparin sodium suppliers exist by strength and presentation?
Supplier count depends on which manufacturing sites produce:
- Each dose strength (eg, IU/mL equivalents as marketed)
- Each presentation (prefilled syringe format, needle configuration, pack size)
- Each regulatory market (US vs EU vs other jurisdictions)
A robust supplier map must be presentation-level because syringe filling, labeling, and packaging are frequently site-specific.
Which patent estate influences dalteparin sodium manufacturing and supplier entry?
Dalteparin sodium is generally treated as an older biologic-like polysaccharide product where entry barriers are often regulatory and process-based rather than purely composition-of-matter patents. Supplier entry is also constrained by:
- Process control IP around depolymerization/fractionation
- Sterile formulation and manufacturing process know-how
- Regulatory comparability requirements for any “follow-on” product
How IP affects suppliers
For a prospective supplier, the patent estate affects:
- Capability to operate a non-infringing manufacturing route
- Licensing needs for specific protected process parameters
- Risk of litigation exposure if the supplier’s process mirrors protected fractionation outcomes
What generic or follow-on risks exist for dalteparin sodium procurement?
LMWH follow-ons face risks distinct from small molecules:
- Proving comparable molecular weight distribution and biological activity
- Achieving equivalent clinical performance and safety in anticoagulation
- Maintaining consistent anti-Xa and anti-IIa activity profiles
- Passing regulatory scrutiny for biosimilar-like comparability even when regulated under non-biologic frameworks (jurisdiction dependent)
What FDA regulatory status affects dalteparin sodium supplier availability?
In the US, dalteparin sodium is approved as a listed drug under an NDA/approved application, with manufacturing sites governed by FDA labeling and CMC sections. Supplier availability is shaped by:
- The approved manufacturing sites for each presentation
- Inspection outcomes for sterile manufacturing facilities
- Drug shortages or allocation history in FDA and market signals
What EU regulatory pathways affect dalteparin sodium follow-on suppliers?
In the EU, follow-on products may be approved under pathways for chemical/biological medicines depending on regulatory classification, with requirements for:
- Demonstrating physicochemical similarity
- Demonstrating functional activity equivalence (anti-Xa activity)
- Manufacturing comparability and validation
This tends to limit the number of qualified suppliers.
Supplier due diligence checklist for dalteparin sodium (procurement-ready)
For procurement, the supplier shortlist should be built on objective evidence tied to specific presentations:
- Site-level qualification
- Approved drug substance manufacturing site
- Approved sterile fill/finish site
- Batch release capability
- Ability to release consistent lots for target strengths and packaging
- Sterile injectable compliance
- Facility readiness for anticoagulant handling and aseptic processing
- Heparin supply traceability
- Porcine source traceability and documentation
- Regulatory alignment
- Ability to meet labeled specifications and shelf-life
- Supply continuity
- Proven ability to maintain continuity under GMP inspection cycles
Key Takeaways
- Dalteparin sodium supply is constrained by heparin-derived LMWH process control and sterile injectable manufacturing capacity.
- “Supplier” should be treated as a presentation-specific plant capability: drug substance manufacturing plus sterile fill/finish, not just a trading distributor.
- Supplier shortlisting for procurement requires site-level evidence tied to FDA/EU approved manufacturing locations and validated sterile production.
FAQs
- How do I identify the approved manufacturing sites for dalteparin sodium in a specific market?
- Do dalteparin sodium shortages reflect sterile filling capacity or upstream heparin supply?
- What documentation is most important when qualifying a new dalteparin sodium sterile fill supplier?
- How does molecular weight distribution impact regulatory acceptance for dalteparin follow-ons?
- What presentation-specific differences (prefilled syringe vs vial) change supplier eligibility?
References
- FDA. Drug shortages database (dalteparin sodium / Fragmin entries, where applicable). U.S. Food and Drug Administration.
- EMA. European public assessment reports (EPAR) and product information for Fragmin (dalteparin) and related products. European Medicines Agency.
- US FDA prescribing information and associated CMC/manufacturing site listings for Fragmin (dalteparin sodium). U.S. Food and Drug Administration.
