Suppliers / Catalent Pharma Solutions

Catalent Pharma Solutions

United States Updated 9 July 2026

Catalent Pharma Solutions is a finished-dose manufacturer based in United States. It appears in 76 regulatory filings across 9 regulators, without an active US DMF or CEP on file. Its filings concentrate with DIGEMAPS (DO), ARCSA (EC) and MINSA (CR). Its GMP standing is certified by ANVISA (Brazil), MHRA (UK) and US FDA. Its most recent recorded inspection, by US FDA, closed on 30 January 2026 as VAI.

0
active US DMFs
0
valid CEPs
10
registered plants 5 with an FDA FEI number
76
filings across 9 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
5 of 5 confirmed
Inspections
8 of 8 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 30 January 2026 VAI US FDA
  • 17 December 2025 NAI US FDA
  • 5 June 2025 NAI US FDA
  • 22 April 2025 VAI US FDA
  • 30 May 2024 NAI US FDA
  • 24 May 2024 VAI US FDA
  • 11 January 2023 VAI US FDA
  • 15 December 2022 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 States Not on file
NEW JERSEY 08873, United States Not on file
WINCHESTER, United States Not on file
ST PETERSBURG, United States Not on file
ST. PETERSBURG, United States Not on file
Morrisville, United States 1000110912

4 further sites are on record.

Filings and GMP by regulator

Regulator Filings GMP certificates
DIGEMAPS (DO) 32 None
ARCSA (EC) 20 None
MINSA (CR) 10 None
INVIMA (CO) 5 None
NPRA (MY) 3 None
EDA (EG) 2 None
ANVISA (Brazil) None 6
MHRA (UK) None 5
US FDA None 4

Questions about Catalent Pharma Solutions

Does Catalent Pharma Solutions hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Catalent Pharma Solutions. It does have 76 filings with 9 regulators, so it is registered, just not with the two strong registers buyers usually screen on.
Is Catalent Pharma Solutions FDA-registered?
5 sites operated by Catalent Pharma Solutions 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 Pharma Solutions's last inspection go?
The most recent inspection on record closed on 30 January 2026 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 8 inspections are on file.
Where does Catalent Pharma Solutions manufacture?
10 registered sites are on record, in United States (Kansas City, NEW Jersey 08873 and Winchester among others). Every site is listed on this page with the register it came from.
Which regulators recognise Catalent Pharma Solutions's GMP?
Current GMP certificates are on record from ANVISA (Brazil), MHRA (UK) 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

  • 45 active litigation matters are on record.
  • The most recent inspection outcome was VAI, on 30 January 2026.

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Sources on this page

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