Gedatolisib
Who holds supplier records for Gedatolisib? No organisation holds a current US Type II DMF or EU CEP for Gedatolisib in the registers PharmaTek covers.
Sources: FDA Drug Master File list, EDQM certification database, FDA Orange Book. Record updated 2 Nov 2026. How we read these records
Reading the evidence
- No current DMF or CEP on record
The covered registers hold no supplier record for this substance. This is not evidence that no one makes it: suppliers may file under another name, sell outside the US and EU, or use an ASMF.
Current records (0)
Organisations holding an active US FDA Type II Drug Master File or a CEP for Gedatolisib. Country is the organisation's recorded country, not necessarily the manufacturing site.
Not found in the covered registers (FDA DMF list, EDQM). This is not evidence that no supplier exists.
The Sourcing Desk contacts candidates, confirms current supply, grade and site, and screens each against its regulatory record, for a buyer-paid fixed fee and never a supplier commission.
US product patents and exclusivity
The FDA Orange Book lists patents and exclusivities for specific approved products (1 listed product contain Gedatolisib). The latest listed exclusivity runs to 14 Jul 2031. These dates are product-specific: they can cover a formulation, a combination or a method of use, and do not on their own show whether the ingredient is protected or whether generics are already approved. Check the individual product entries before planning a launch.
Overview
Gedatolisib is a small molecule active pharmaceutical ingredient (ChEMBL CHEMBL592445).
Chemical identity
- IUPAC name
- 1-[4-[4-(dimethylamino)piperidine-1-carbonyl]phenyl]-3-[4-(4,6-dimorpholin-4-yl-1,3,5-triazin-2-yl)phenyl]urea
- Canonical SMILES
- CN(C)C1CCN(CC1)C(=O)C2=CC=C(C=C2)NC(=O)NC3=CC=C(C=C3)C4=NC(=NC(=N4)N5CCOCC5)N6CCOCC6
- InChIKey
- DWZAEMINVBZMHQ-UHFFFAOYSA-N
- Synonyms
- Gedatolisib, PF-05212384, PKI-587, PKI 587, PKI587, PF 05212384, gedatolisibum, RefChem:922134, Gedatolisib (PF-05212384, PKI-587), PKI-587; PF-05212384, PF-05212384 (PKI-587), Gedatolisib [USAN:INN]
Record history
PharmaTek records which organisations hold a current DMF or CEP for Gedatolisib every week, starting 23 Oct 2026. Additions and lapses will appear here from the next weekly release.
Monitoring pilot: get an email when these records change. Places are confirmed by a person; nothing is sent until then. All changes this week
What these records establish
- An active DMF means a confidential file is held by the FDA and can be referenced; the FDA does not approve or disapprove DMFs.
- A CEP confirms monograph suitability for the EU market; it is not a GMP certificate, and the holder may not be the manufacturer.
- Historical records show a past filing, not current supply.
- Company GMP certificates are matched to the organisation, not to the site making this substance.
- A substance missing from these registers is not evidence that no supplier exists.
Do you supply Gedatolisib?
Send a link to a certificate, registration or filing we have missed or got wrong. We check it against the issuing register before changing anything; information we cannot check against a register is shown as supplier-reported.