Suppliers / Inke

Inke

Spain reconciled across 4 public records · 2 entities Updated 9 July 2026

Inke is an API manufacturer based in Spain. It holds 24 active US drug master files across a filed portfolio of 21 molecules. Its most recent recorded inspection, by US FDA, closed on 15 March 2023 as VAI.

24
active US DMFs
0
valid CEPs
1
registered plants 1 with an FDA FEI number
0
filings across 0 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
5 of 5 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 15 March 2023 VAI US FDA
  • 10 April 2019 VAI US FDA
  • 15 April 2016 NAI US FDA
  • 25 January 2013 VAI US FDA
  • 25 July 2009 VAI US FDA

NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.

Registered plants

Site FDA FEI
Spain, Spain 3003663245

What they file, and where

Molecule Regulators Docs
Arformoterol US FDA 4
Granisetron US FDA 4
Ondansetron US FDA 4
Aclidinium Bromide US FDA 2
Aprepitant US FDA 2
Clevidipine US FDA 2
Fluconazole US FDA 2
Formoterol US FDA 2
Glycopyrronium US FDA 2
Indacaterol US FDA 2
Show all 21 molecules on file
Olanzapine US FDA 2
Olodaterol US FDA 2
Revefenacin US FDA 2
Risperidone US FDA 2
Rizatriptan US FDA 2
Salmeterol US FDA 2
Tetrabenazine US FDA 2
Tiotropium US FDA 2
Umeclidinium Bromide US FDA 2
Vilanterol US FDA 2
Zolmitriptan US FDA 2

Also appears on these molecule pages

Aprepitant API Arformoterol API Clevidipine API Fluconazole API Formoterol API Glycopyrronium API Granisetron API Indacaterol API Ondansetron API Revefenacin API Risperidone API Rizatriptan API
Show 7 more molecule pages
Salmeterol API Tetrabenazine API Tiotropium API Umeclidinium API Vilanterol API Zolmitriptan API Olanzapine API

Questions about Inke

Does Inke hold a US DMF or a CEP?
Inke holds 24 active US drug master files. A drug master file is a submission to the FDA describing how an ingredient is made; a CEP is the EDQM's certificate that the substance meets its European Pharmacopoeia monograph. Both are filings rather than approvals.
Is Inke FDA-registered?
One site operated by Inke carries an FDA establishment identifier (FEI), which means it is registered with the FDA as a drug establishment. Registration is not the same as approval or inspection clearance.
How did Inke's last inspection go?
The most recent inspection on record closed on 15 March 2023 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 5 inspections are on file.
Where does Inke manufacture?
1 registered site is on record, in Spain (Spain). Every site is listed on this page with the register it came from.
What does Inke make?
21 molecules are on record against Inke, including Arformoterol, Granisetron, Ondansetron and Aclidinium Bromide. Each links through to that molecule's full manufacturer list.

Answered from this company's own record. Where a register holds nothing, the question is not asked rather than answered with a zero. How we count our figures.

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Open risk flags

  • 1 active litigation matter is on record.
  • The most recent inspection outcome was VAI, on 15 March 2023.

Comparable suppliers

Cipla shares 14 molecules Dr Reddy's Laboratories shares 7 molecules MSN Laboratories shares 6 molecules Apitoria Pharma shares 6 molecules Alivus Life Sciences shares 6 molecules

Ranked by shared active ingredients where we have them, otherwise by country and comparable credentials.

Sources on this page

FDA
Drug master files, establishment registration, inspection classifications
EDQM
Certificates of suitability