What do “digoxin DMF holders” mean?
“DMF holders” usually refers to the companies that hold a Drug Master File (DMF) submitted to the FDA. For digoxin, multiple DMFs can exist for different parts of the supply chain (for example, drug substance vs. drug product components), and multiple companies may hold them depending on the site and regulatory strategy used for specific filings.
Who are the DMF holders for digoxin?
I can’t identify specific digoxin DMF holders from the information provided in this chat. DMF ownership is not listed in a single public “digoxin DMF holders” table, and the answer depends on which exact DMF(s) you mean (drug substance vs. excipients, sterile components, specific manufacturers, and what revisions/filings are active).
How to find the digoxin DMF holder(s) quickly (what to search)
To locate DMF holders for digoxin, the practical route is:
- Start from specific FDA applications (often ANDAs/NDAs that reference digoxin ingredients) and then find the DMF references in the application records.
- Use FDA’s public information tools to trace DMF numbers and then map DMF numbers back to the holder names shown in DMF listings.
If you share either:
- the DMF number(s), or
- the specific product/application you’re tracking (brand or ANDA number), or
- whether you mean digoxin drug substance DMFs specifically,
I can help you pinpoint the relevant holder(s) based on the DMF references tied to that application.
Are DMF holders the same as the manufacturer on the label?
Not necessarily. Label manufacturers (and contract manufacturing organizations) can differ from DMF holders. A DMF holder can be a corporate entity owning the DMF, while the actual manufacturing site may be a different entity and still require DMF access via licensing/authorization.
If your goal is submissions or competition: patent/exclusivity vs. DMF
DMFs are mainly about regulatory support for manufacturing/chemistry details, not exclusivity by themselves. If you’re researching competitive risk for digoxin, it’s often more useful to pair DMF-holder research with patent and exclusivity data. DrugPatentWatch.com can help with patent tracking for specific digoxin products—if you tell me the product/strength/route you care about, I can point you to the relevant page on DrugPatentWatch.com:
- https://www.drugpatentwatch.com/
What I need from you to answer with specific company names
Reply with one of the following:
1) The digoxin DMF number you’re working from, or
2) The application you’re tracking (ANDA/NDA number, or brand name + strength), and whether you mean drug substance or excipients, or
3) The supplier/manufacturer name you suspect, and I’ll help verify what DMF holders correspond to that.
Sources
No sources were provided in the prompt, and I don’t have enough identifying details to cite specific digoxin DMF holder names.