Tegoprazan

CAS 942195-55-3 5 current recordsSmall Molecule

Who holds supplier records for Tegoprazan? 5 organisations hold a current record for Tegoprazan: an active US FDA Type II Drug Master File. Recorded organisation countries for current records: India (3), United States (1) and China (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

  • 5 current records

    Several organisations hold current DMFs or CEPs. Whether any is a usable source for your grade, scale and market still needs qualification.

  • Most recorded organisations are in India

    3 of the 5 current records with a recorded country list India. Organisation country is not necessarily the manufacturing site.

  • 2 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 (5)

Organisations holding an active US FDA Type II Drug Master File or a CEP for Tegoprazan. Country is the organisation's recorded country, not necessarily the manufacturing site.

India3United States1China1
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Overview

Tegoprazan is a small molecule active pharmaceutical ingredient (ChEMBL CHEMBL4297583).

Chemical identity

IUPAC name
7-[[(4S)-5,7-difluoro-3,4-dihydro-2H-chromen-4-yl]oxy]-N,N,2-trimethyl-3H-benzimidazole-5-carboxamide
Canonical SMILES
CC1=NC2=C(N1)C=C(C=C2O[C@H]3CCOC4=C3C(=CC(=C4)F)F)C(=O)N(C)C
InChIKey
CLIQCDHNPDMGSL-HNNXBMFYSA-N
Synonyms
Cj-12420, Lxi-15028, LXI-15028, Tegoprazan, K-CAB, tegoprazanum, RefChem:187715, Tegoprazan [INN], Tegoprazan (INN), Tegoprazan?, Tegoprazan (Standard), TEGOPRAZAN [WHO-DD]

Record history

PharmaTek records which organisations hold a current DMF or CEP for Tegoprazan 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 Tegoprazan?

5 organisations hold an active US FDA Type II Drug Master File or a CEP for Tegoprazan: BRAINTREE LABORATORIES INC (United States), LEE PHARMA LTD (India), METROCHEM API PRIVATE LTD (India), MSN LIFE SCIENCES PRIVATE LIMITED (India) and SHANGHAI HAOYUAN CHEMEXPRESS CO LTD (China). A DMF or CEP shows a regulatory filing, not current commercial availability, and the holder is not necessarily the manufacturing site.

Which Tegoprazan Drug Master Files are active?

BRAINTREE LABORATORIES INC (DMF 42368), LEE PHARMA LTD (DMF 39156), METROCHEM API PRIVATE LTD (DMF 38991), MSN LIFE SCIENCES PRIVATE LIMITED (DMF 43826) and SHANGHAI HAOYUAN CHEMEXPRESS CO LTD (DMF 43136). 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 Tegoprazan 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.

For suppliers

Do you supply Tegoprazan?

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.

Free. Payment never buys an evidence status.