Suppliers / Bidachem

Bidachem

Italy 87 employees Updated 9 July 2026

Bidachem is an API manufacturer based in Italy. It holds one active US drug master file and 6 valid CEPs across a filed portfolio of 6 molecules. Its GMP standing is certified by US FDA. Its most recent recorded inspection, by US FDA, closed on 17 May 2024 as VAI.

1
active US DMFs
6
valid CEPs
2
registered plants 1 with an FDA FEI number
3
filings across 1 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
7 of 7 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 17 May 2024 VAI US FDA
  • 23 November 2018 VAI US FDA
  • 18 May 2018 NAI US FDA
  • 2 June 2016 NAI US FDA
  • 17 July 2013 NAI US FDA
  • 14 September 2012 NAI US FDA
  • 24 July 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
Fornovo San Giovanni, Italy Not on file
Italy, Italy 3002806598

What they file, and where

Molecule Regulators Docs
Ambroxol EDQM, SFDA (Saudi Arabia) 2
Bisacodyl EDQM 2
Bromhexine EDQM 1
Meloxicam US FDA 1
Orciprenaline EDQM 1
Sodium Picosulfate EDQM 1

Also appears on these molecule pages

Ambroxol API Bisacodyl API Bromhexine API Meloxicam API

Filings and GMP by regulator

Regulator Filings GMP certificates
MINSA (CR) 3 None
US FDA None 1

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Open risk flags

  • The most recent inspection outcome was VAI, on 17 May 2024.

Sources on this page

FDA
Drug master files, establishment registration, inspection classifications
EDQM
Certificates of suitability
EudraGMDP and national regulators
GMP certificates