Suppliers / Xellia Pharmaceuticals

Xellia Pharmaceuticals

Denmark 946 employees reconciled across 9 public records · 7 entities Updated 9 July 2026

Xellia Pharmaceuticals is an API and finished-dose manufacturer based in Denmark. It holds 19 active US drug master files across a filed portfolio of 10 molecules. Its filings concentrate with US FDA, EMA and MPA (SE). Its GMP standing is certified by EDQM and EMA. Its most recent recorded inspection, by US FDA, closed on 28 October 2021 as VAI.

19
active US DMFs
0
valid CEPs
6
registered plants 2 with an FDA FEI number
58
filings across 12 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

  • 28 October 2021 VAI US FDA
  • 25 October 2019 VAI US FDA
  • 8 May 2018 VAI US FDA
  • 6 April 2018 VAI US FDA
  • 15 March 2016 VAI US FDA
  • 26 March 2015 NAI US FDA
  • 6 May 2014 VAI US FDA
  • 16 October 2012 VAI US FDA
  • 20 September 2012 NAI US FDA
  • 11 February 2010 VAI US FDA
  • 27 February 2009 NAI US FDA

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

Registered plants

Site FDA FEI
Kobenhavn S, United Arab Emirates Not on file
Taizhou, China Not on file
China, China 3007422723
COPENHAGEN, Denmark Not on file
Denmark, Denmark 3002806860
Copenhagen S, Denmark Not on file

What they file, and where

Molecule Regulators Docs
Vancomycin SFDA (Saudi Arabia), US FDA 9
Amphotericin B SFDA (Saudi Arabia), US FDA 4
Bacitracin US FDA 4
Gramicidin D SFDA (Saudi Arabia), US FDA 4
Colistimethate SFDA (Saudi Arabia), US FDA 3
Daptomycin SFDA (Saudi Arabia), US FDA 3
Polymyxin B US FDA 2
Tobramycin US FDA 2
Colistin US FDA 1
Dalbavancin US FDA 1

Also appears on these molecule pages

Colistin API Dalbavancin API Daptomycin contract manufacturing Polymyxin B API Tobramycin contract manufacturing Vancomycin contract manufacturing Voriconazole finished dose

Filings and GMP by regulator

Regulator Filings GMP certificates
US FDA 12 None
EMA 10 4
MPA (SE) 10 None
AIFA (IT) 8 None
INFARMED (PT) 5 None
JFDA (JO) 3 None
EDQM None 12

Questions about Xellia Pharmaceuticals

Does Xellia Pharmaceuticals hold a US DMF or a CEP?
Xellia Pharmaceuticals holds 19 active US drug master files. 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 Xellia Pharmaceuticals FDA-registered?
2 sites operated by Xellia 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 Xellia Pharmaceuticals's last inspection go?
The most recent inspection on record closed on 28 October 2021 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 11 inspections are on file.
Where does Xellia Pharmaceuticals manufacture?
6 registered sites are on record, in United Arab Emirates, China and Denmark (Kobenhavn S, Taizhou and China among others). Every site is listed on this page with the register it came from.
What does Xellia Pharmaceuticals make?
10 molecules are on record against Xellia Pharmaceuticals, including Vancomycin, Amphotericin B, Bacitracin and Gramicidin D. Each links through to that molecule's full manufacturer list.
Which regulators recognise Xellia Pharmaceuticals's GMP?
Current GMP certificates are on record from EDQM 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

  • 6 active litigation matters are on record.
  • The most recent inspection outcome was VAI, on 28 October 2021.

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Livzon Group Fuzhou Fuxing Pharmaceutical shares 6 molecules Chengdu Yacht Biotechnology shares 3 molecules Chongqing Daxin Pharmaceutical shares 3 molecules Zhejiang Medicine shares 2 molecules Hangzhou Zhongmei Huadong Pharmaceutical shares 2 molecules

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