Suppliers / Catalent Greenville

Catalent Greenville

United States Updated 9 July 2026

Catalent Greenville is a finished-dose manufacturer based in United States. It appears in 10 regulatory filings across 5 regulators, without an active US DMF or CEP on file. Its filings concentrate with INVIMA (CO), NPRA (MY) and ARCSA (EC). Its GMP standing is certified by ANVISA (Brazil) and US FDA. Its most recent recorded inspection, by US FDA, closed on 24 October 2025 as VAI.

0
active US DMFs
0
valid CEPs
2
registered plants 1 with an FDA FEI number
10
filings across 5 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

  • 24 October 2025 VAI US FDA
  • 31 January 2024 NAI US FDA
  • 12 July 2019 VAI US FDA
  • 24 August 2018 NAI US FDA
  • 13 April 2017 NAI US FDA
  • 14 July 2016 NAI US FDA
  • 2 May 2014 NAI US FDA
  • 21 August 2013 NAI US FDA

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

Registered plants

Site FDA FEI
GREENVILLE, United States Not on file
Greenville, United States 3000209735

Filings and GMP by regulator

Regulator Filings GMP certificates
INVIMA (CO) 3 None
NPRA (MY) 3 None
ARCSA (EC) 2 None
DIGEMAPS (DO) 1 None
MINSA (CR) 1 None
ANVISA (Brazil) None 2
US FDA None 1

Questions about Catalent Greenville

Does Catalent Greenville hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Catalent Greenville. It does have 10 filings with 5 regulators, so it is registered, just not with the two strong registers buyers usually screen on.
Is Catalent Greenville FDA-registered?
One site operated by Catalent Greenville 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 Greenville's last inspection go?
The most recent inspection on record closed on 24 October 2025 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 8 inspections are on file.
Where does Catalent Greenville manufacture?
2 registered sites are on record, in United States (Greenville and Greenville). Every site is listed on this page with the register it came from.
Which regulators recognise Catalent Greenville's GMP?
Current GMP certificates are on record from ANVISA (Brazil) 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 24 October 2025.

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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