Suppliers / Viatris Pharmaceuticals

Viatris Pharmaceuticals

United States 2 duplicate records merged Updated 9 July 2026

Viatris Pharmaceuticals is a finished-dose manufacturer based in United States. It appears in 17 regulatory filings across 1 regulator, without an active US DMF or CEP on file. Its GMP standing is certified by ANVISA (Brazil), MFDS (Korea) and EAEU_EEC, among 4 authorities. Its most recent recorded inspection, by US FDA, closed on 13 June 2025 as NAI.

0
active US DMFs
0
valid CEPs
4
registered plants 2 with an FDA FEI number
17
filings across 1 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
2 of 2 confirmed
Inspections
8 of 8 confirmed
EU GMP
1 of 1 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026. EudraGMDP (MIA + third-country GMP certs), read 4 May 2026.

Inspection history

  • 13 June 2025 NAI US FDA
  • 17 February 2022 VAI US FDA
  • 20 December 2019 VAI US FDA
  • 28 March 2018 VAI US FDA
  • 26 January 2018 VAI US FDA
  • 8 December 2016 NAI US FDA
  • 26 July 2016 VAI US FDA
  • 2 July 2015 VAI US FDA

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

Registered plants

Site FDA FEI
BARCELONETA, Puerto Rico Not on file
VENTURA, United States Not on file
Vega Baja, United States 2623619
Barceloneta, United States 2627208

Filings and GMP by regulator

Regulator Filings GMP certificates
ARCSA (EC) 17 None
ANVISA (Brazil) None 6
MFDS (Korea) None 2
EAEU_EEC None 2
US FDA None 1

Questions about Viatris Pharmaceuticals

Does Viatris Pharmaceuticals hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Viatris Pharmaceuticals. It does have 17 filings with one regulator, so it is registered, just not with the two strong registers buyers usually screen on.
Is Viatris Pharmaceuticals FDA-registered?
2 sites operated by Viatris Pharmaceuticals 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 Viatris Pharmaceuticals's last inspection go?
The most recent inspection on record closed on 13 June 2025 as NAI (No Action Indicated: nothing objectionable was found). 8 inspections are on file.
Where does Viatris Pharmaceuticals manufacture?
4 registered sites are on record, in Puerto Rico and United States (Barceloneta, Ventura and Vega Baja among others). Every site is listed on this page with the register it came from.
Which regulators recognise Viatris Pharmaceuticals's GMP?
Current GMP certificates are on record from ANVISA (Brazil), MFDS (Korea), EEC (Eurasian Economic Union) 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 NAI, on 13 June 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