Suppliers / Alpex Pharma

Alpex Pharma

Switzerland 64 employees Updated 9 July 2026

Alpex Pharma is a contract manufacturer based in Switzerland. It appears in 17 regulatory filings across 5 regulators, without an active US DMF or CEP on file. Its filings concentrate with EMA, URPL (PL) and ANSM (FR). Its GMP standing is certified by US FDA and FDA (GH). Its most recent recorded inspection, by US FDA, closed on 14 December 2023 as VAI.

0
active US DMFs
0
valid CEPs
2
registered plants 1 with an FDA FEI number
17
filings across 5 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
3 of 3 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 14 December 2023 VAI US FDA
  • 21 August 2015 NAI US FDA
  • 24 February 2011 NAI US FDA

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

Registered plants

Site FDA FEI
Mezzovico-Vira, Switzerland Not on file
Switzerland, Switzerland 3004311700

Filings and GMP by regulator

Regulator Filings GMP certificates
EMA 7 None
URPL (PL) 5 None
ANSM (FR) 2 None
NPRA (MY) 2 None
UZPHARM (UZ) 1 None
US FDA None 1
FDA (GH) None 1

Questions about Alpex Pharma

Does Alpex Pharma hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Alpex Pharma. It does have 17 filings with 5 regulators, so it is registered, just not with the two strong registers buyers usually screen on.
Is Alpex Pharma FDA-registered?
One site operated by Alpex Pharma 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 Alpex Pharma's last inspection go?
The most recent inspection on record closed on 14 December 2023 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 3 inspections are on file.
Where does Alpex Pharma manufacture?
2 registered sites are on record, in Switzerland (Mezzovico-vira and Switzerland). Every site is listed on this page with the register it came from.
Which regulators recognise Alpex Pharma's GMP?
Current GMP certificates are on record from US FDA and FDA (GH). 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 14 December 2023.

Comparable suppliers

Acino Pharma also in Switzerland Baccinex also in Switzerland Bracco Suisse also in Switzerland Drossapharm also in Switzerland F.Hoffmann-La Roche also in Switzerland

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