Which companies (or applicants) filed European Drug Master Files (DMFs) for heparin sodium?
To answer this, I’d need a specific detail about what you mean by “applicants” in the European context (for example: the DMF holder listed on regulatory documents, or the marketing-authorisation applicant for a product that relies on a heparin sodium DMF). The information is also not contained in the prompt you provided.
If you share any of the following, I can pinpoint the relevant European DMF applicants more precisely:
- the country regulator route you care about (EMA vs a specific national authority),
- whether you mean “Drug Master File (DMF)” in the European Pharmacopoeia/Quality context or “sponsor/holder” in a marketing authorisation,
- the exact heparin sodium product name(s) or marketing authorisation (MA) number(s),
- the DMF identifier(s) (DMF reference number) if you have them.
How to identify heparin sodium DMF holders/applicants in Europe
In practice, “applicant/holder” data for DMFs is usually tied to:
- the quality documentation referenced by an application (quality part), and/or
- a DMF holder’s legal entity name as listed in regulatory submissions.
The most reliable way is to start from the marketing authorisation dossiers for heparin sodium products that cite the DMF. Then you can trace to the quality source/provider listed alongside the DMF.
If you tell me a specific heparin sodium brand/product (or the EMA product name), I can narrow the search to the likely DMF holder names tied to that dossier.
Does your question mean “European Pharmacopoeia DMF” or “DMF in the EMA submission”?
People use “DMF” differently in Europe. Some searches are really about:
- European Pharmacopoeia “manufacturer”/“supplier” quality sections, not a standalone DMF number, or
- the applicant listed in EMA product documentation (marketing authorisation holder), not the DMF legal entity.
Clarifying which one you mean will change the names you’re looking for.
If you meant an MA holder (marketing authorisation applicant) for heparin sodium
If what you want is the companies marketing heparin sodium medicines in Europe (rather than the DMF holder), I can compile that from the relevant product dossiers—but again I need the product name(s) or at least which strength/form (e.g., heparin sodium injection) and which jurisdictions.
Next step
Reply with either:
1) the heparin sodium product name(s) (or MA numbers), or
2) the DMF reference number(s) you saw, or
3) which European authority you’re using as the starting point (EMA vs national).
Then I can list the European DMF “applicants/holders” (company names) tied to heparin sodium based on the documents you’re referencing.