Suppliers / Excella Gmbh

Excella Gmbh

Germany 110 employees 5 duplicate records merged Updated 9 July 2026

Excella Gmbh is an API and finished-dose manufacturer based in Germany. It holds 26 active US drug master files and 23 valid CEPs. Its filings concentrate with MINSA (CR), ARCSA (EC) and INVIMA (CO). Its GMP standing is certified by ZLG (DE), ANVISA (Brazil) and EMA, among 6 authorities. Its most recent recorded inspection, by US FDA, closed on 19 October 2022 as VAI.

26
active US DMFs
23
valid CEPs
6
registered plants 1 with an FDA FEI number
51
filings across 7 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
7 of 7 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

  • 19 October 2022 VAI US FDA
  • 12 July 2019 VAI US FDA
  • 17 March 2017 NAI US FDA
  • 29 May 2015 VAI US FDA
  • 17 May 2013 VAI US FDA
  • 10 October 2012 VAI US FDA
  • 12 March 2010 NAI US FDA

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

Registered plants

Site FDA FEI
Feucht, United Arab Emirates Not on file
Feucht, United Arab Emirates Not on file
FEUCHT, Germany Not on file
Feucht, Germany Not on file
Germany, Germany 3000242652
Feucht Germany, Nigeria Not on file

What they file, and where

Molecule Regulators Docs
Methotrexate EDQM, SFDA (Saudi Arabia), US FDA 6
Anastrozole EDQM, SFDA (Saudi Arabia), US FDA 4
Timolol EDQM, SFDA (Saudi Arabia), US FDA 4
Acyclovir EDQM, SFDA (Saudi Arabia), US FDA 3
Deferoxamine SFDA (Saudi Arabia), US FDA 3
Ganciclovir EDQM, US FDA 3
Levothyroxine EDQM, SFDA (Saudi Arabia), US FDA 3
Baclofen EDQM, US FDA 2
Bicalutamide EDQM, US FDA 2
Bupivacaine EDQM, US FDA 2
Show all 30 molecules on file
Haloperidol EDQM, US FDA 2
Masitinib US FDA 2
Ropivacaine SFDA (Saudi Arabia), US FDA 2
Tamoxifen EDQM, US FDA 2
Temozolomide EDQM, US FDA 2
Adapalene US FDA 1
Alfuzosin EDQM 1
Azathioprine EDQM 1
Buspirone US FDA 1
Busulfan EDQM 1
Capecitabine SFDA (Saudi Arabia) 1
Cevimeline US FDA 1
Deferoxamine Mesilate EDQM 1
Dobutamine EDQM 1
Doxazosin US FDA 1
Doxazosin Mesilate EDQM 1
Lanthanum Carbonate US FDA 1
Mianserin EDQM 1
Mycophenolic Acid US FDA 1
Talazoparib SFDA (Saudi Arabia) 1

Also appears on these molecule pages

Acyclovir API Adapalene API Alectinib finished dose Alfuzosin API Anastrozole API Azathioprine API Baclofen API Bicalutamide API Bosutinib finished dose Bupivacaine API Buspirone API Busulfan API
Show 18 more molecule pages
Capecitabine API Cevimeline API Dobutamine API Doxazosin API Doxazosin Mesilate API Ganciclovir API Haloperidol API Lanthanum Carbonate API Levothyroxine API Macitentan finished dose Melphalan finished dose Methotrexate API Mycophenolic Acid API Ropivacaine API Selexipag finished dose Tamoxifen API Temozolomide API Timolol API

Filings and GMP by regulator

Regulator Filings GMP certificates
MINSA (CR) 20 None
ARCSA (EC) 15 None
INVIMA (CO) 10 None
NAFDAC (NG) 2 1
NCELS (KZ) 2 1
BOMRA (BW) 1 None
ZLG (DE) None 16
ANVISA (Brazil) None 7
EMA None 2
MFDS (Korea) None 2

Questions about Excella Gmbh

Does Excella Gmbh hold a US DMF or a CEP?
Excella Gmbh holds 26 active US drug master files and 23 valid CEPs. A drug master file is a submission to the FDA describing how an ingredient is made; a CEP is the EDQM's certificate that the substance meets its European Pharmacopoeia monograph. Both are filings rather than approvals.
Is Excella Gmbh FDA-registered?
One site operated by Excella Gmbh 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 Excella Gmbh's last inspection go?
The most recent inspection on record closed on 19 October 2022 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 7 inspections are on file.
Where does Excella Gmbh manufacture?
6 registered sites are on record, in United Arab Emirates, Germany and Nigeria (Feucht, Feucht and Germany among others). Every site is listed on this page with the register it came from.
What does Excella Gmbh make?
30 molecules are on record against Excella Gmbh, including Methotrexate, Anastrozole, Timolol and Acyclovir. Each links through to that molecule's full manufacturer list.
Which regulators recognise Excella Gmbh's GMP?
Current GMP certificates are on record from ZLG (DE), ANVISA (Brazil), EMA, MFDS (Korea), NCELS (KZ) 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 19 October 2022.

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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