Suppliers / Merck Serono

Merck Serono

Switzerland 2 duplicate records merged Updated 9 July 2026

Merck Serono is a finished-dose manufacturer based in Switzerland. It appears in 151 regulatory filings across 22 regulators, without an active US DMF or CEP on file. Its filings concentrate with AIFA (IT), ARCSA (EC) and EDA (EG). Its GMP standing is certified by MHRA (UK), EMA and ANVISA (Brazil), among 4 authorities. Its most recent recorded inspection, by US FDA, closed on 2 May 2023 as NAI.

0
active US DMFs
0
valid CEPs
9
registered plants 2 with an FDA FEI number
151
filings across 22 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

  • 2 May 2023 NAI US FDA
  • 6 April 2023 VAI US FDA
  • 18 February 2020 VAI US FDA
  • 9 May 2018 VAI US FDA
  • 30 April 2018 NAI US FDA
  • 5 February 2016 VAI US FDA
  • 6 November 2015 VAI US FDA
  • 12 November 2013 VAI US FDA

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

Registered plants

Site FDA FEI
CH- 1170 Aubonne, United Arab Emirates Not on file
Modugno (BA), United Arab Emirates Not on file
AUBONNE, Switzerland Not on file
Switzerland, Switzerland 3003131678
Switzerland, Switzerland 3002807447
Aubonne, Switzerland Not on file

3 further sites are on record.

Filings and GMP by regulator

Regulator Filings GMP certificates
AIFA (IT) 28 None
ARCSA (EC) 18 None
EDA (EG) 13 None
SFDA (Saudi Arabia) 10 None
ANSM (FR) 9 None
MPA (SE) 8 None
MHRA (UK) None 4
EMA None 2
ANVISA (Brazil) None 2
NAFDAC (NG) None 1

Questions about Merck Serono

Does Merck Serono hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Merck Serono. It does have 151 filings with 22 regulators, so it is registered, just not with the two strong registers buyers usually screen on.
Is Merck Serono FDA-registered?
2 sites operated by Merck Serono 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 Merck Serono's last inspection go?
The most recent inspection on record closed on 2 May 2023 as NAI (No Action Indicated: nothing objectionable was found). 8 inspections are on file.
Where does Merck Serono manufacture?
9 registered sites are on record, in United Arab Emirates, Switzerland, United Kingdom and Nigeria (Ch- 1170 Aubonne, Modugno (ba) and Aubonne among others). Every site is listed on this page with the register it came from.
Which regulators recognise Merck Serono's GMP?
Current GMP certificates are on record from MHRA (UK), EMA, ANVISA (Brazil) and NAFDAC (NG). 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 2 May 2023.

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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