Suppliers / Catalent Cts

Catalent Cts

United States Updated 9 July 2026

Catalent Cts is a finished-dose manufacturer based in United States. It appears in 17 regulatory filings across 8 regulators, without an active US DMF or CEP on file. Its filings concentrate with INVIMA (CO), ARCSA (EC) and NPRA (MY). Its GMP standing is certified by ANVISA (Brazil), MHRA (UK) and NCELS (KZ). Its most recent recorded inspection, by US FDA, closed on 4 March 2022 as NAI.

0
active US DMFs
0
valid CEPs
6
registered plants 2 with an FDA FEI number
17
filings across 8 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
2 of 2 confirmed
Inspections
8 of 8 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 4 March 2022 NAI US FDA
  • 6 November 2017 NAI US FDA
  • 29 June 2015 NAI US FDA
  • 10 November 2014 VAI US FDA
  • 5 March 2014 NAI US FDA
  • 14 January 2013 NAI US FDA
  • 8 June 2012 NAI US FDA
  • 24 March 2010 VAI US FDA

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

Registered plants

Site FDA FEI
Kansas City, United Arab Emirates Not on file
BATHGATE, United Kingdom Not on file
SWINDON, United Kingdom Not on file
United Kingdom, United Kingdom 3009442470
KANSAS CITY, United States Not on file
Kansas City, United States 3002929455

Filings and GMP by regulator

Regulator Filings GMP certificates
INVIMA (CO) 4 None
ARCSA (EC) 4 None
NPRA (MY) 3 None
NCELS (KZ) 2 1
DIGEMAPS (DO) 1 None
EDE (AE) 1 None
ANVISA (Brazil) None 9
MHRA (UK) None 6

Questions about Catalent Cts

Does Catalent Cts hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Catalent Cts. It does have 17 filings with 8 regulators, so it is registered, just not with the two strong registers buyers usually screen on.
Is Catalent Cts FDA-registered?
2 sites operated by Catalent Cts carry an FDA establishment identifier (FEI), which means they are registered with the FDA as a drug establishment. Registration is not the same as approval or inspection clearance.
How did Catalent Cts's last inspection go?
The most recent inspection on record closed on 4 March 2022 as NAI (No Action Indicated: nothing objectionable was found). 8 inspections are on file.
Where does Catalent Cts manufacture?
6 registered sites are on record, in United Arab Emirates, United Kingdom and United States (Kansas City, Bathgate and Swindon among others). Every site is listed on this page with the register it came from.
Which regulators recognise Catalent Cts's GMP?
Current GMP certificates are on record from ANVISA (Brazil), MHRA (UK) and NCELS (KZ). 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 NAI, on 4 March 2022.

Sources on this page

FDA
Drug master files, establishment registration, inspection classifications
EDQM
Certificates of suitability
EudraGMDP and national regulators
GMP certificates