Inke

Spain 2 duplicate records merged Updated 9 July 2026

Inke is an API manufacturer based in Spain. It holds 48 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.

active US DMFs

valid CEPs

registered plants 1 with an FDA FEI number

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

Fluconazole API Formoterol API Ondansetron API Risperidone API Salmeterol API Tiotropium API Umeclidinium API Vilanterol API Zolmitriptan API Olanzapine API

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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.

Sources on this page

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