Suppliers / Msd International Gmbh (Puerto Rico Branch)

Msd International Gmbh (Puerto Rico Branch)

United States Updated 9 July 2026

Msd International Gmbh (Puerto Rico Branch) is an API and finished-dose manufacturer based in United States. 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
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

  • 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
CLONMEL, Ireland Not on file
Ireland, Ireland 3017657338
Ireland, Ireland 3002807560
Co Dublin, Ireland Not on file
Tipperary, Ireland Not on file
Cork, Ireland Not on file

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

Atorvastatin finished dose Ezetimibe finished dose Ribavirin finished dose Sitagliptin API

Filings and GMP by regulator

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

Questions about Msd International Gmbh (Puerto Rico Branch)

Does Msd International Gmbh (Puerto Rico Branch) hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Msd International Gmbh (Puerto Rico Branch). It does have 8 filings with one regulator, so it is registered, just not with the two strong registers buyers usually screen on.
Is Msd International Gmbh (Puerto Rico Branch) FDA-registered?
4 sites operated by Msd International Gmbh (Puerto Rico Branch) 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 Msd International Gmbh (Puerto Rico Branch)'s last inspection go?
The most recent inspection on record closed on 24 October 2025 as NAI (No Action Indicated: nothing objectionable was found). 8 inspections are on file.
Where does Msd International Gmbh (Puerto Rico Branch) manufacture?
12 registered sites are on record, in Ireland, Puerto Rico and Singapore (Clonmel, Ireland and Co Dublin among others). Every site is listed on this page with the register it came from.
What does Msd International Gmbh (Puerto Rico Branch) make?
1 molecule is on record against Msd International Gmbh (Puerto Rico Branch), including Sitagliptin. Each links through to that molecule's full manufacturer list.
Which regulators recognise Msd International Gmbh (Puerto Rico Branch)'s GMP?
Current GMP certificates are on record from EMA, ANVISA (Brazil), HSA (SG), MHRA (UK), US FDA and 1 more. 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 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