Suppliers / Merck Sharp & Dohme Farmaceutica Ltda

Merck Sharp & Dohme Farmaceutica Ltda

Brazil Updated 9 July 2026

Merck Sharp & Dohme Farmaceutica Ltda is an API and finished-dose manufacturer based in Brazil. It holds one active US drug master file. Its filings concentrate with ANVISA (Brazil), US FDA and BOMRA (BW). Its GMP standing is certified by ANVISA (Brazil), US FDA and MFDS (Korea). Its most recent recorded inspection, by US FDA, closed on 22 January 2025 as VAI.

1
active US DMFs
0
valid CEPs
12
registered plants 6 with an FDA FEI number
341
filings across 5 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
6 of 6 confirmed
Inspections
8 of 8 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 22 January 2025 VAI US FDA
  • 12 December 2024 NAI US FDA
  • 17 October 2024 VAI US FDA
  • 23 August 2024 VAI US FDA
  • 12 June 2024 NAI US FDA
  • 16 November 2023 NAI US FDA
  • 26 April 2023 NAI US FDA
  • 21 April 2023 VAI US FDA

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

Registered plants

Site FDA FEI
Singapore, United Arab Emirates Not on file
SAO PAULO, Brazil Not on file
CAMPINAS, Brazil Not on file
São Paulo, Brazil Not on file
APARECIDA DE GOIÂNIA, Brazil Not on file
Ireland, Ireland 3008694906

6 further sites are on record.

What they file, and where

Molecule Regulators Docs
Betamethasone US FDA 1

Also appears on these molecule pages

Asenapine finished dose Betamethasone API Caspofungin finished dose Cilastatin finished dose Desogestrel finished dose Dexpanthenol finished dose Eptifibatide finished dose Ertapenem finished dose Etonogestrel finished dose Imipenem finished dose Letermovir finished dose Miconazole finished dose
Show 9 more molecule pages
Mirtazapine finished dose Palonosetron finished dose Posaconazole finished dose Raltegravir finished dose Ribavirin finished dose Rocuronium finished dose Simvastatin finished dose Tedizolid finished dose Temozolomide finished dose

Filings and GMP by regulator

Regulator Filings GMP certificates
ANVISA (Brazil) 242 7
US FDA 89 5
BOMRA (BW) 5 None
ARCSA (EC) 4 None
DIGEMAPS (DO) 1 None
MFDS (Korea) None 2

Questions about Merck Sharp & Dohme Farmaceutica Ltda

Does Merck Sharp & Dohme Farmaceutica Ltda hold a US DMF or a CEP?
Merck Sharp & Dohme Farmaceutica Ltda holds 1 active US drug master file. A drug master file is a submission to the FDA describing how an ingredient is made; a CEP is the EDQM's certificate that the substance meets its European Pharmacopoeia monograph. Both are filings rather than approvals.
Is Merck Sharp & Dohme Farmaceutica Ltda FDA-registered?
6 sites operated by Merck Sharp & Dohme Farmaceutica Ltda 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 Sharp & Dohme Farmaceutica Ltda's last inspection go?
The most recent inspection on record closed on 22 January 2025 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 8 inspections are on file.
Where does Merck Sharp & Dohme Farmaceutica Ltda manufacture?
12 registered sites are on record, in United Arab Emirates, Brazil, Ireland and Netherlands (Singapore, SAO Paulo and Campinas among others). Every site is listed on this page with the register it came from.
What does Merck Sharp & Dohme Farmaceutica Ltda make?
1 molecule is on record against Merck Sharp & Dohme Farmaceutica Ltda, including Betamethasone. Each links through to that molecule's full manufacturer list.
Which regulators recognise Merck Sharp & Dohme Farmaceutica Ltda's GMP?
Current GMP certificates are on record from ANVISA (Brazil), US FDA and MFDS (Korea). 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

  • 30 active litigation matters are on record.
  • The most recent inspection outcome was VAI, on 22 January 2025.

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Ranked by shared active ingredients where we have them, otherwise by country and comparable credentials.

Sources on this page

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