Iptacopan Hydrochloride
Who holds supplier records for Iptacopan Hydrochloride? 1 organisation holds a current record for Iptacopan Hydrochloride: an active US FDA Type II Drug Master File. Recorded organisation countries for current records: India (1).
Sources: FDA Drug Master File list, EDQM certification database, FDA Orange Book. Record updated 4 Aug 2026. How we read these records
Reading the evidence
- One current record
One organisation holds a current DMF or CEP. A record shows a regulatory filing, not current commercial availability or a qualified source for your product.
- 1 with a company-level GMP certificate on record
These organisations have at least one current EU or UK GMP certificate somewhere. It is not matched to the site that makes this substance; check the certificate's site and scope.
Current records (1)
Organisations holding an active US FDA Type II Drug Master File or a CEP for Iptacopan Hydrochloride. Country is the organisation's recorded country, not necessarily the manufacturing site.
- Alembic Pharmaceuticals LimitedIndia Company GMP cert on recordActive DMF 44267 · latest filing Jun 2026
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.
Overview
Iptacopan Hydrochloride is a small molecule active pharmaceutical ingredient (ChEMBL CHEMBL5095401).
Chemical identity
- IUPAC name
- 4-[(2S,4S)-4-ethoxy-1-[(5-methoxy-7-methyl-1H-indol-4-yl)methyl]piperidin-2-yl]benzoic acid;hydrate;hydrochloride
- Canonical SMILES
- CCO[C@H]1CCN([C@@H](C1)C2=CC=C(C=C2)C(=O)O)CC3=C(C=C(C4=C3C=CN4)C)OC.O.Cl
- InChIKey
- JUWBBUFSAGEROP-VVJLZRNGSA-N
- Synonyms
- Fabhalta, Iptacopan hydrochloride, Iptacopan hydrochloride monohydrate, LNP-023-AAB, LNP023-AAB, LNP-023 HYDROCHLORIDE MONOHYDRATE, NVP-LNP023-AAB, Iptacopan hydrochloride [USAN], RefChem:148678, iptacopan hydrochloride hydrate, orb1739852, EX-A5728A
Record history
PharmaTek records which organisations hold a current DMF or CEP for Iptacopan Hydrochloride 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.
Frequently asked questions
Which organisations hold current supplier records for Iptacopan Hydrochloride?
1 organisation holds an active US FDA Type II Drug Master File or a CEP for Iptacopan Hydrochloride: Alembic Pharmaceuticals Limited (India). A DMF or CEP shows a regulatory filing, not current commercial availability, and the holder is not necessarily the manufacturing site.
Which Iptacopan Hydrochloride Drug Master Files are active?
Alembic Pharmaceuticals Limited (DMF 44267). The FDA does not approve or disapprove DMFs; an active DMF can be referenced in an application once its holder issues a letter of authorisation.
How do I qualify a Iptacopan Hydrochloride supplier?
Confirm the DMF or CEP is current and covers your grade, obtain the letter of authorisation, identify the actual manufacturing site and check its GMP certificate and FDA inspection history, audit the site or review a recent audit, and run comparable requests for information across more than one candidate.
Do you supply Iptacopan Hydrochloride?
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.