Suppliers / Pharmachemie

Pharmachemie

Netherlands 1 employees 2 duplicate records merged Updated 9 July 2026

Pharmachemie is a finished-dose manufacturer based in Netherlands. It appears in 58 regulatory filings across 10 regulators, without an active US DMF or CEP on file. Its filings concentrate with US FDA, NMRC (NA) and EDA (EG). Its GMP standing is certified by ANVISA (Brazil), MFDS (Korea) and EMA, among 5 authorities. Its most recent recorded inspection, by US FDA, closed on 17 October 2024 as VAI.

0
active US DMFs
0
valid CEPs
3
registered plants 1 with an FDA FEI number
58
filings across 10 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
6 of 6 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

  • 17 October 2024 VAI US FDA
  • 9 September 2021 NAI US FDA
  • 17 May 2019 NAI US FDA
  • 29 May 2015 NAI US FDA
  • 28 June 2013 VAI US FDA
  • 19 February 2010 VAI US FDA

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

Registered plants

Site FDA FEI
HAARLEM, Netherlands Not on file
Netherlands, Netherlands 3002807910
Noord-Holland, Netherlands Not on file

Filings and GMP by regulator

Regulator Filings GMP certificates
US FDA 14 1
NMRC (NA) 12 None
EDA (EG) 9 None
NAFDAC (NG) 8 1
MPA (SE) 4 None
DMP (NO) 3 None
ANVISA (Brazil) None 2
MFDS (Korea) None 2
EMA None 1

Questions about Pharmachemie

Does Pharmachemie hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Pharmachemie. It does have 58 filings with 10 regulators, so it is registered, just not with the two strong registers buyers usually screen on.
Is Pharmachemie FDA-registered?
One site operated by Pharmachemie carries an FDA establishment identifier (FEI), which means it is registered with the FDA as a drug establishment. Registration is not the same as approval or inspection clearance.
How did Pharmachemie's last inspection go?
The most recent inspection on record closed on 17 October 2024 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 6 inspections are on file.
Where does Pharmachemie manufacture?
3 registered sites are on record, in Netherlands (Haarlem, Netherlands and Noord-holland). Every site is listed on this page with the register it came from.
Which regulators recognise Pharmachemie's GMP?
Current GMP certificates are on record from ANVISA (Brazil), MFDS (Korea), EMA, NAFDAC (NG) and US FDA. 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

  • 2 active litigation matters are on record.
  • The most recent inspection outcome was VAI, on 17 October 2024.

Comparable suppliers

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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