Suppliers / Merck Sharp & Dohme

Merck Sharp & Dohme

United States Updated 9 July 2026

Merck Sharp & Dohme is a finished-dose manufacturer based in United States. It appears in 1,463 regulatory filings across 15 regulators, without an active US DMF or CEP on file. Its filings concentrate with AIFA (IT), FAMHP (BE) and MPA (SE). Its GMP standing is certified by ANVISA (Brazil) and EMA.

0
active US DMFs
0
valid CEPs
2
registered plants
1,463
filings across 15 regulators
These figures were checked against the regulators' own files on 25 July 2026
EU GMP
1 of 1 confirmed
Sources: EudraGMDP (MIA + third-country GMP certs), read 4 May 2026.

Registered plants

Site FDA FEI
Haarlem, United Arab Emirates Not on file
HAARLEM, Netherlands Not on file

Filings and GMP by regulator

Regulator Filings GMP certificates
AIFA (IT) 432 None
FAMHP (BE) 413 None
MPA (SE) 232 None
EMA 154 1
INFARMED (PT) 153 None
DMP (NO) 18 None
ANVISA (Brazil) None 3

Questions about Merck Sharp & Dohme

Does Merck Sharp & Dohme hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Merck Sharp & Dohme. It does have 1,463 filings with 15 regulators, so it is registered, just not with the two strong registers buyers usually screen on.
Where does Merck Sharp & Dohme manufacture?
2 registered sites are on record, in United Arab Emirates and Netherlands (Haarlem and Haarlem). Every site is listed on this page with the register it came from.
Which regulators recognise Merck Sharp & Dohme's GMP?
Current GMP certificates are on record from ANVISA (Brazil) and EMA. 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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Sources on this page

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