Suppliers / AESICA Pharmaceuticals

AESICA Pharmaceuticals

Germany Updated 9 July 2026

AESICA Pharmaceuticals is a finished-dose manufacturer based in Germany. It appears in 43 regulatory filings across 8 regulators, without an active US DMF or CEP on file. Its filings concentrate with MINSA (CR), ARCSA (EC) and INVIMA (CO). Its GMP standing is certified by ZLG (DE), ANVISA (Brazil) and EMA, among 5 authorities. Its most recent recorded inspection, by US FDA, closed on 12 September 2024 as VAI.

0
active US DMFs
0
valid CEPs
8
registered plants 2 with an FDA FEI number
43
filings across 8 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
2 of 2 confirmed
Inspections
8 of 8 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

  • 12 September 2024 VAI US FDA
  • 31 August 2023 VAI US FDA
  • 1 July 2021 VAI US FDA
  • 30 August 2019 NAI US FDA
  • 20 September 2017 NAI US FDA
  • 2 December 2016 VAI US FDA
  • 20 June 2014 VAI US FDA
  • 17 January 2014 NAI US FDA

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

Registered plants

Site FDA FEI
Monheim, United Arab Emirates Not on file
Pianezza, United Arab Emirates Not on file
WESTPHALIA, Germany Not on file
Saxony, Germany Not on file
Germany, Germany 3002948883
Monheim Am Rhein, Germany Not on file

2 further sites are on record.

Filings and GMP by regulator

Regulator Filings GMP certificates
MINSA (CR) 18 None
ARCSA (EC) 7 None
INVIMA (CO) 6 None
EDE (AE) 6 None
UZPHARM (UZ) 3 None
NPRA (MY) 1 None
ZLG (DE) None 18
ANVISA (Brazil) None 8
EMA None 3
US FDA None 2
MFDS (Korea) None 2

Questions about AESICA Pharmaceuticals

Does AESICA Pharmaceuticals hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for AESICA Pharmaceuticals. It does have 43 filings with 8 regulators, so it is registered, just not with the two strong registers buyers usually screen on.
Is AESICA Pharmaceuticals FDA-registered?
2 sites operated by AESICA Pharmaceuticals carry an FDA establishment identifier (FEI), which means they are registered with the FDA as a drug establishment. Registration is not the same as approval or inspection clearance.
How did AESICA Pharmaceuticals's last inspection go?
The most recent inspection on record closed on 12 September 2024 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 8 inspections are on file.
Where does AESICA Pharmaceuticals manufacture?
8 registered sites are on record, in United Arab Emirates and Germany (Monheim, Pianezza and Westphalia among others). Every site is listed on this page with the register it came from.
Which regulators recognise AESICA Pharmaceuticals's GMP?
Current GMP certificates are on record from ZLG (DE), ANVISA (Brazil), EMA, US FDA and MFDS (Korea). 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 12 September 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