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

Questions about ROTOP Pharmaka

Does ROTOP Pharmaka hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for ROTOP Pharmaka. It does have 87 filings with 10 regulators, so it is registered, just not with the two strong registers buyers usually screen on.
Is ROTOP Pharmaka FDA-registered?
One site operated by ROTOP Pharmaka 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 ROTOP Pharmaka's last inspection go?
The most recent inspection on record closed on 2 July 2021 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 2 inspections are on file.
Where does ROTOP Pharmaka manufacture?
3 registered sites are on record, in Germany (Dresden, Saxony and Germany). Every site is listed on this page with the register it came from.
Which regulators recognise ROTOP Pharmaka'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 2 July 2021.

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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