Suppliers / Vertex Pharmaceuticals

Vertex Pharmaceuticals

United States Updated 9 July 2026

Vertex Pharmaceuticals is a finished-dose manufacturer based in United States. It appears in 288 regulatory filings across 15 regulators, without an active US DMF or CEP on file. Its filings concentrate with Health Canada, AIFA (IT) and FAMHP (BE). Its GMP standing is certified by MHRA (UK), US FDA and ANVISA (Brazil). Its most recent recorded inspection, by US FDA, closed on 3 March 2026 as NAI.

0
active US DMFs
0
valid CEPs
6
registered plants 1 with an FDA FEI number
288
filings across 15 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

  • 3 March 2026 NAI US FDA
  • 1 August 2024 NAI US FDA
  • 4 May 2023 VAI US FDA
  • 19 August 2022 NAI US FDA
  • 5 October 2017 NAI US FDA
  • 21 September 2016 VAI US FDA
  • 29 April 2015 VAI US FDA
  • 17 February 2015 NAI US FDA

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

Registered plants

Site FDA FEI
Zug, Switzerland Not on file
LONDON, United Kingdom Not on file
Montijo, Portugal Not on file
Riyadh, Saudi Arabia Not on file
BOSTON, United States Not on file
Boston, United States 1000513211

Filings and GMP by regulator

Regulator Filings GMP certificates
Health Canada 52 None
AIFA (IT) 27 None
FAMHP (BE) 25 None
MPA (SE) 21 None
DKMA (DK) 21 None
INFARMED (PT) 21 None
MHRA (UK) None 6
US FDA None 1
ANVISA (Brazil) None 1

Questions about Vertex Pharmaceuticals

Does Vertex Pharmaceuticals hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Vertex Pharmaceuticals. It does have 288 filings with 15 regulators, so it is registered, just not with the two strong registers buyers usually screen on.
Is Vertex Pharmaceuticals FDA-registered?
One site operated by Vertex Pharmaceuticals 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 Vertex Pharmaceuticals's last inspection go?
The most recent inspection on record closed on 3 March 2026 as NAI (No Action Indicated: nothing objectionable was found). 8 inspections are on file.
Where does Vertex Pharmaceuticals manufacture?
6 registered sites are on record, in Switzerland, United Kingdom, Portugal and Saudi Arabia (Zug, London and Montijo among others). Every site is listed on this page with the register it came from.
Which regulators recognise Vertex Pharmaceuticals's GMP?
Current GMP certificates are on record from MHRA (UK), US FDA and ANVISA (Brazil). 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 3 March 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