Suppliers / Catalent U.K. Swindon Zydis

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.

0
active US DMFs
0
valid CEPs
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
Plants
1 of 1 confirmed
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

Questions about Catalent U.K. Swindon Zydis

Does Catalent U.K. Swindon Zydis hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Catalent U.K. Swindon Zydis. It does have 23 filings with 8 regulators, so it is registered, just not with the two strong registers buyers usually screen on.
Is Catalent U.K. Swindon Zydis FDA-registered?
One site operated by Catalent U.K. Swindon Zydis 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 Catalent U.K. Swindon Zydis's last inspection go?
The most recent inspection on record closed on 10 October 2024 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 8 inspections are on file.
Where does Catalent U.K. Swindon Zydis manufacture?
2 registered sites are on record, in United Arab Emirates and United Kingdom (Swindon and United Kingdom). Every site is listed on this page with the register it came from.
Which regulators recognise Catalent U.K. Swindon Zydis's GMP?
Current GMP certificates are on record from NAFDAC (NG) and US FDA. GMP recognition covers the manufacturing site, separately from any filing on the substance itself.

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

  • The most recent inspection outcome was VAI, on 10 October 2024.

Comparable suppliers

ALMAC Pharma Services also in United Kingdom Almac Sciences also in United Kingdom AstraZeneca UK also in United Kingdom Bard Pharmaceuticals also in United Kingdom Bell, Sons & Co (Druggists) also in United Kingdom

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
EudraGMDP and national regulators
GMP certificates