Suppliers / Pharbil Waltrop

Pharbil Waltrop

Germany Updated 9 July 2026

Pharbil Waltrop is a finished-dose manufacturer based in Germany. It appears in 12 regulatory filings across 6 regulators, without an active US DMF or CEP on file. Its filings concentrate with EMA, EDE (AE) and ARCSA (EC). Its GMP standing is certified by ZLG (DE) and EMA. Its most recent recorded inspection, by US FDA, closed on 14 February 2020 as VAI.

0
active US DMFs
0
valid CEPs
5
registered plants 1 with an FDA FEI number
12
filings across 6 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
4 of 4 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

  • 14 February 2020 VAI US FDA
  • 22 June 2018 VAI US FDA
  • 24 January 2014 NAI US FDA
  • 30 October 2008 VAI US FDA

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

Registered plants

Site FDA FEI
Waltrop, United Arab Emirates Not on file
WALTROP, Germany Not on file
Nordrhein-Westfalen, Germany Not on file
Germany, Germany 3004620586
North Rhine-Westphalia, Germany Not on file

Filings and GMP by regulator

Regulator Filings GMP certificates
EMA 5 3
EDE (AE) 2 None
ARCSA (EC) 2 None
NPRA (MY) 1 None
UZPHARM (UZ) 1 None
DIGEMAPS (DO) 1 None
ZLG (DE) None 12

Questions about Pharbil Waltrop

Does Pharbil Waltrop hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Pharbil Waltrop. It does have 12 filings with 6 regulators, so it is registered, just not with the two strong registers buyers usually screen on.
Is Pharbil Waltrop FDA-registered?
One site operated by Pharbil Waltrop 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 Pharbil Waltrop's last inspection go?
The most recent inspection on record closed on 14 February 2020 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 4 inspections are on file.
Where does Pharbil Waltrop manufacture?
5 registered sites are on record, in United Arab Emirates and Germany (Waltrop, Waltrop and Nordrhein-westfalen among others). Every site is listed on this page with the register it came from.
Which regulators recognise Pharbil Waltrop's GMP?
Current GMP certificates are on record from ZLG (DE) 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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Open risk flags

  • The most recent inspection outcome was VAI, on 14 February 2020.

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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