Surface DMF holders with active filings but no observable shipment activity. The qualified-but-not-shipping cohort that breaks supplier-discovery shortlists.
An estimated 1,400+ Type II DMF holders carry active filings but no observable customs export activity in the trailing 24 months. The cohort is roughly 28% of the active DMF register and breaks supplier-discovery shortlists if not filtered: a holder may be qualified on paper but operationally inactive, mid-tech-transfer, or carrying a stale filing the firm never withdrew. The detector flags the mismatch between regulatory active status and commercial active status.
| # | Holder | Region | Active DMFs | Last shipment observed | Detector chip |
|---|---|---|---|---|---|
| 1 | Innovare Labs | IN · Hyderabad | 1 active DMF | Mar 2021 | NAI |
| 2 | Niche API Holder (synthetic) | IN · long-tail | 1 active DMF | 2020 last | VAI |
| 3 | Cipla Salcette (paper subset) | IN · Goa | 2 active DMF | active | VAI |
| 4 | Wuhan API Holder (synthetic) | CN · Hubei | 1 active DMF | 2022 last | VAI |
| 5 | Innovator backup DMF | DE · multi-site | 2 active DMF | innovator-only | NAI |
| 6 | Long-tail single-filer | IN · varied | 1 active DMF | no shipment | VAI |
The molecule's active DMF cohort or an uploaded supplier list. PharmaDB resolves each row to a plant entity.
Trade flows activity over the trailing 24 months. Holders with active DMF and no observable shipments get a paper-only chip.
Citation-anchored cohort with the paper-only holders flagged separately. Useful before issuing an RFQ or qualifying a supplier.
DMF status says regulatory active. Customs activity says commercial active. The detector flags the mismatch so the buyer does not waste qualification time on a non-shipping holder.
Holders whose last DMF amendment is older than five years get an additional stale-filing chip. Stale filings combined with no shipments are the strongest paper-only signal.
Originator companies often maintain DMF filings on molecules they no longer commercially ship. The detector flags innovator paper-only holders separately because the qualification path is different.
Filterable per molecule. A buyer can see the paper-only ratio on rivaroxaban vs apixaban vs sacubitril to understand how thin the actually-shipping cohort is.
A real chat thread in PharmaDB. Type a question, the AI agent runs the tools, the answer lands as a saveable note.
pharmagraph_query Approximate paper-only proportion of active Type II DMF holders by molecule · the qualification false-positive cohort.
The paper-only detector is the regulatory vs commercial mismatch filter. PharmaDB joins DMF active status to trade flows activity at the plant entity and flags the gap. The view is api_docs joined to the customs export view. Refresh cadence is weekly.
A Type II DMF holder with active regulatory status but no observable cross-border export activity in the trailing 24 months. The filing is alive on the FDA register; the supplier is operationally inactive on the molecule in question. The mismatch creates qualification false positives if not filtered.
DMF maintenance is annual and inexpensive. Filings persist beyond commercial activity because the holder may pursue future opportunities, may use the filing as a competitive shield, or may have lost the commercial wind-down decision to administrative inertia. Roughly 28% of the active DMF surface is paper-only at any time.
No. Recent filings (under 12 months) may simply not have started shipping. Innovator filings on legacy products may be valid backup paths. The detector tiers paper-only into hard (stale, no shipments) and soft (recent filing, no shipments yet) so the buyer can decide.
Trade flows records over the trailing 24 months, aggregated and anonymised. The signal is shipment count and dollar weight at the plant level. A holder with zero shipments at any of its plants flips to paper-only.
Customs activity refreshes weekly. DMF status refreshes weekly. The detector chip refreshes on each catalog cycle. Each row carries the last-shipment-observed date and the DMF amendment date.
Yes. EU CEP holders, EDQM Type I filings, and Japanese DMF equivalents are tracked with the same trade overlay. Cross-registry paper-only views surface in a combined cohort for buyers serving multi-regulator markets.
Bring the molecule, the lane, or the supplier you're sourcing this week. The AI agent runs it on PharmaDB in 30 minutes. You keep the brief.