Catalent U.K. Swindon Zydis
United Kingdom Updated 9 July 2026
Catalent U.K. Swindon Zydis is a finished-dose manufacturer based in United Kingdom. It appears in 23 regulatory filings across 8 regulators, without an active US DMF or CEP on file. Its filings concentrate with MINSA (CR), ARCSA (EC) and DIGEMAPS (DO). Its GMP standing is certified by NAFDAC (NG) and US FDA. Its most recent recorded inspection, by US FDA, closed on 10 October 2024 as VAI.
2
registered plants
1 with an FDA FEI number
23
filings
across 8 regulators
These figures were checked against the regulators' own files on 25 July 2026
Inspections
8 of 8 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.
Inspection history
- 10 October 2024 VAI US FDA
- 15 June 2023 VAI US FDA
- 20 February 2020 VAI US FDA
- 26 July 2018 VAI US FDA
- 15 September 2016 NAI US FDA
- 6 September 2016 VAI US FDA
- 12 September 2014 VAI US FDA
- 18 November 2011 VAI US FDA
NAI means no action indicated, VAI means voluntary action indicated, and OAI means
official action indicated.
Registered plants
| Site | FDA FEI |
| SWINDON, United Arab Emirates | Not on file |
| United Kingdom, United Kingdom | 3003812585 |
Filings and GMP by regulator
| Regulator | Filings | GMP certificates |
| MINSA (CR) | 8 | None |
| ARCSA (EC) | 5 | None |
| DIGEMAPS (DO) | 3 | None |
| INVIMA (CO) | 2 | None |
| NAFDAC (NG) | 2 | 1 |
| JFDA (JO) | 1 | None |
| US FDA | None | 1 |
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Open risk flags
- The most recent inspection outcome was VAI, on 10 October 2024.
Sources on this page
- FDA
- Drug master files, establishment registration, inspection classifications
- EDQM
- Certificates of suitability
- EudraGMDP and national regulators
- GMP certificates