Suppliers / Rottendorf Pharma

Rottendorf Pharma

Germany 388 employees 2 duplicate records merged Updated 9 July 2026

Rottendorf Pharma is a finished-dose manufacturer based in Germany. It appears in 7 regulatory filings across 1 regulator, without an active US DMF or CEP on file. Its GMP standing is certified by ZLG (DE), ANVISA (Brazil) and MFDS (Korea), among 6 authorities. Its most recent recorded inspection, by US FDA, closed on 14 March 2024 as VAI.

0
active US DMFs
0
valid CEPs
6
registered plants 1 with an FDA FEI number
7
filings across 1 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

  • 14 March 2024 VAI US FDA
  • 6 May 2021 VAI US FDA
  • 21 February 2019 VAI US FDA
  • 3 February 2017 VAI US FDA
  • 14 March 2014 NAI US FDA
  • 30 March 2012 VAI US FDA

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

Registered plants

Site FDA FEI
Ennigerloh, United Arab Emirates Not on file
North Rhine-Westphalia, Germany Not on file
ENNIGERLOH, Germany Not on file
Beckum, Germany Not on file
Germany, Germany 3003732290
Ostenfelder Strabe 51-61 Ennlgerloh, Nigeria Not on file

Filings and GMP by regulator

Regulator Filings GMP certificates
NAFDAC (NG) 7 1
ZLG (DE) None 12
ANVISA (Brazil) None 11
MFDS (Korea) None 2
EMA None 2
US FDA None 1

Questions about Rottendorf Pharma

Does Rottendorf Pharma hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Rottendorf Pharma. It does have 7 filings with one regulator, so it is registered, just not with the two strong registers buyers usually screen on.
Is Rottendorf Pharma FDA-registered?
One site operated by Rottendorf Pharma 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 Rottendorf Pharma's last inspection go?
The most recent inspection on record closed on 14 March 2024 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 6 inspections are on file.
Where does Rottendorf Pharma manufacture?
6 registered sites are on record, in United Arab Emirates, Germany and Nigeria (Ennigerloh, North Rhine-westphalia and Ennigerloh among others). Every site is listed on this page with the register it came from.
Which regulators recognise Rottendorf Pharma's GMP?
Current GMP certificates are on record from ZLG (DE), ANVISA (Brazil), MFDS (Korea), EMA, NAFDAC (NG) and 1 more. 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 March 2024.

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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