Suppliers / Msd International Gmbh (Puerto Rico Branch)

Msd International Gmbh (Puerto Rico Branch)

Ireland Updated 9 July 2026

Msd International Gmbh (Puerto Rico Branch) is an API and finished-dose manufacturer based in Ireland. It appears in 8 regulatory filings across 1 regulator, without an active US DMF or CEP on file. Its GMP standing is certified by EMA, ANVISA (Brazil) and HSA (SG), among 6 authorities. Its most recent recorded inspection, by US FDA, closed on 24 October 2025 as NAI.

0
active US DMFs
0
valid CEPs
12
registered plants 4 with an FDA FEI number
8
filings across 1 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
4 of 4 confirmed
Inspections
4 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

  • 24 October 2025 NAI US FDA
  • 10 September 2025 VAI US FDA
  • 20 June 2025 VAI US FDA
  • 30 May 2025 NAI US FDA
  • 24 March 2023 VAI US FDA
  • 21 December 2022 VAI US FDA
  • 23 June 2022 NAI US FDA
  • 13 May 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
Ireland, Ireland 3017657338
CLONMEL, Ireland Not on file
Tipperary, Ireland Not on file
Ireland, Ireland 3002807560
Carlow, Ireland Not on file
Ireland, Ireland 3002808087

6 further sites are on record.

What they file, and where

Molecule Regulators Docs
Sitagliptin SFDA (Saudi Arabia) 1

Also appears on these molecule pages

Filings and GMP by regulator

Regulator Filings GMP certificates
MINSA (CR) 8 None
EMA None 20
ANVISA (Brazil) None 6
HSA (SG) None 6
US FDA None 4
MHRA (UK) None 4
MFDS (Korea) None 2

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Open risk flags

  • The most recent inspection outcome was NAI, on 24 October 2025.

Sources on this page

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