Suppliers / Merck Sharp & Dohme

Merck Sharp & Dohme

United States 6 duplicate records merged Updated 9 July 2026

The public registers hold a second record for Merck Sharp & Dohme. The fuller profile, with 0 active US DMFs and 0 valid CEPs, is at Merck Sharp & Dohme. Figures on this page cover only this record.

Merck Sharp & Dohme is an API manufacturer based in United States. It appears in 180 regulatory filings across 16 regulators, without an active US DMF or CEP on file. Its filings concentrate with RAMA (GE), INFARMED (PT) and SFDA (Saudi Arabia). Its GMP standing is certified by NAFDAC (NG).

0
active US DMFs
0
valid CEPs
3
registered plants
180
filings across 16 regulators

Registered plants

Site FDA FEI
Wilson, United Arab Emirates Not on file
PA, Nigeria Not on file
WEST POINT, United States Not on file

What they file, and where

Molecule Regulators Docs
Cilastatin SFDA (Saudi Arabia) 1
Imipenem SFDA (Saudi Arabia) 1

Also appears on these molecule pages

Cilastatin API Imipenem API

Filings and GMP by regulator

Regulator Filings GMP certificates
RAMA (GE) 32 None
INFARMED (PT) 25 None
SFDA (Saudi Arabia) 24 None
EMA 23 None
MPA (SE) 17 None
ARCSA (EC) 17 None
NAFDAC (NG) None 1

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 180 filings with 16 regulators, so it is registered, just not with the two strong registers buyers usually screen on.
Where does Merck Sharp & Dohme manufacture?
3 registered sites are on record, in United Arab Emirates, Nigeria and United States (Wilson, PA and West Point). Every site is listed on this page with the register it came from.
What does Merck Sharp & Dohme make?
2 molecules are on record against Merck Sharp & Dohme, including Cilastatin and Imipenem. Each links through to that molecule's full manufacturer list.
Which regulators recognise Merck Sharp & Dohme's GMP?
Current GMP certificates are on record from 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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Sources on this page

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