Suppliers / Ucb Pharma

Ucb Pharma

Belgium Updated 9 July 2026

Ucb Pharma is an API and finished-dose manufacturer based in Belgium. It holds 2 active US drug master files. Its filings concentrate with MHRA (UK), AIFA (IT) and FAMHP (BE). Its GMP standing is certified by MHRA (UK), ZLG (DE) and EMA, among 6 authorities. Its most recent recorded inspection, by US FDA, closed on 1 February 2024 as VAI.

2
active US DMFs
0
valid CEPs
12
registered plants 2 with an FDA FEI number
1,521
filings across 28 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

  • 1 February 2024 VAI US FDA
  • 4 July 2023 VAI US FDA
  • 25 November 2021 VAI US FDA
  • 30 April 2018 NAI US FDA
  • 27 January 2017 VAI US FDA
  • 11 September 2015 NAI US FDA
  • 16 December 2014 VAI US FDA
  • 21 November 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
Braine-l'Alleud, United Arab Emirates Not on file
Braine-L'Alleud, Belgium Not on file
BRAINE-L'ALLEUD, Belgium Not on file
Braine-Lalleud, Belgium Not on file
Braine-L'Alleud, Belgium Not on file
Belgium, Belgium 3003909356

6 further sites are on record.

What they file, and where

Molecule Regulators Docs
Cetirizine US FDA 2

Also appears on these molecule pages

Amitriptyline finished dose Baclofen finished dose Brivaracetam finished dose Carbidopa finished dose Cetirizine API Codeine finished dose Cromoglicic Acid finished dose Hydrocodone finished dose Hydroxyzine finished dose Lacosamide finished dose Levetiracetam finished dose Levocetirizine finished dose
Show 6 more molecule pages
Midazolam finished dose Piracetam finished dose Pseudoephedrine finished dose Rotigotine finished dose Sodium Oxybate finished dose Somatostatin finished dose

Filings and GMP by regulator

Regulator Filings GMP certificates
MHRA (UK) 378 8
AIFA (IT) 258 None
FAMHP (BE) 206 None
EMA 102 3
US FDA 78 2
MPA (SE) 74 None
ZLG (DE) None 4
NAFDAC (NG) None 3
ANVISA (Brazil) None 3

Questions about Ucb Pharma

Does Ucb Pharma hold a US DMF or a CEP?
Ucb Pharma holds 2 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 Ucb Pharma FDA-registered?
2 sites operated by Ucb Pharma 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 Ucb Pharma's last inspection go?
The most recent inspection on record closed on 1 February 2024 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 8 inspections are on file.
Where does Ucb Pharma manufacture?
12 registered sites are on record, in United Arab Emirates, Belgium, Switzerland and Germany (Braine-l'alleud, Braine-l'alleud and Braine-l'alleud among others). Every site is listed on this page with the register it came from.
What does Ucb Pharma make?
1 molecule is on record against Ucb Pharma, including Cetirizine. Each links through to that molecule's full manufacturer list.
Which regulators recognise Ucb Pharma's GMP?
Current GMP certificates are on record from MHRA (UK), ZLG (DE), EMA, NAFDAC (NG), ANVISA (Brazil) 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

  • 8 active litigation matters are on record.
  • The most recent inspection outcome was VAI, on 1 February 2024.

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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