Suppliers / ROTOP Pharmaka

ROTOP Pharmaka

Germany 97 employees Updated 9 July 2026

ROTOP Pharmaka is a finished-dose manufacturer based in Germany. It appears in 87 regulatory filings across 10 regulators, without an active US DMF or CEP on file. Its filings concentrate with EMA, AIFA (IT) and INFARMED (PT). Its GMP standing is certified by ZLG (DE) and EMA. Its most recent recorded inspection, by US FDA, closed on 2 July 2021 as VAI.

0
active US DMFs
0
valid CEPs
3
registered plants 1 with an FDA FEI number
87
filings across 10 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
2 of 2 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

  • 2 July 2021 VAI US FDA
  • 7 December 2018 VAI US FDA

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

Registered plants

Site FDA FEI
Dresden, Germany Not on file
Saxony, Germany Not on file
Germany, Germany 3009075542

Filings and GMP by regulator

Regulator Filings GMP certificates
EMA 60 1
AIFA (IT) 5 None
INFARMED (PT) 4 None
INVIMA (CO) 4 None
ANSM (FR) 3 None
FAMHP (BE) 3 None
ZLG (DE) None 6

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Open risk flags

  • The most recent inspection outcome was VAI, on 2 July 2021.

Sources on this page

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