Suppliers / Lonza

Lonza

Switzerland 2 duplicate records merged Updated 9 July 2026

Lonza is an API manufacturer based in Switzerland. It holds 5 active US drug master files and 4 valid CEPs across a filed portfolio of 9 molecules. Its filings concentrate with ARCSA (EC), MINSA (CR) and INVIMA (CO). Its GMP standing is certified by EMA, MHRA (UK) and HSA (SG), among 7 authorities. Its most recent recorded inspection, by US FDA, closed on 6 February 2026 as VAI.

5
active US DMFs
4
valid CEPs
12
registered plants 5 with an FDA FEI number
21
filings across 4 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
5 of 5 confirmed
Inspections
6 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

  • 6 February 2026 VAI US FDA
  • 7 March 2024 VAI US FDA
  • 21 July 2023 VAI US FDA
  • 27 June 2023 VAI US FDA
  • 28 March 2023 VAI US FDA
  • 4 November 2022 NAI US FDA
  • 13 October 2022 VAI US FDA
  • 5 August 2022 VAI US FDA

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

Registered plants

Site FDA FEI
Geleen, United Arab Emirates Not on file
Braine-Lalleud, Belgium Not on file
Braine-L'Alleud, Belgium Not on file
Switzerland, Switzerland 3016502617
Switzerland, Switzerland 3012793444
Stein Ag, Switzerland Not on file

6 further sites are on record.

What they file, and where

Molecule Regulators Docs
Nicotinamide EDQM, US FDA 2
Nicotinic Acid EDQM 2
Desmopressin EDQM 1
Dexmethylphenidate US FDA 1
Fluvoxamine US FDA 1
Macitentan SFDA (Saudi Arabia) 1
Pomalidomide SFDA (Saudi Arabia) 1
Sirolimus US FDA 1
Voclosporin US FDA 1

Also appears on these molecule pages

Desmopressin API Dexmethylphenidate API Fluvoxamine API L-Glutamine contract manufacturing Macitentan API Pomalidomide API Sirolimus API Voclosporin API

Filings and GMP by regulator

Regulator Filings GMP certificates
ARCSA (EC) 11 None
MINSA (CR) 4 None
INVIMA (CO) 4 None
EEC_EAEU 2 None
EMA None 11
MHRA (UK) None 7
HSA (SG) None 2
MFDS (Korea) None 2
US FDA None 2
ANVISA (Brazil) None 1
AEMPS (ES) None 1

Questions about Lonza

Does Lonza hold a US DMF or a CEP?
Lonza holds 5 active US drug master files and 4 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 Lonza FDA-registered?
5 sites operated by Lonza 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 Lonza's last inspection go?
The most recent inspection on record closed on 6 February 2026 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 8 inspections are on file.
Where does Lonza manufacture?
12 registered sites are on record, in United Arab Emirates, Belgium, Switzerland and China (Geleen, Braine-lalleud and Braine-l'alleud among others). Every site is listed on this page with the register it came from.
What does Lonza make?
9 molecules are on record against Lonza, including Nicotinamide, Nicotinic Acid, Desmopressin and Dexmethylphenidate. Each links through to that molecule's full manufacturer list.
Which regulators recognise Lonza's GMP?
Current GMP certificates are on record from EMA, MHRA (UK), HSA (SG), MFDS (Korea), US FDA and 2 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

  • 2 active litigation matters are on record.
  • The most recent inspection outcome was VAI, on 6 February 2026.

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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