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

Questions about Bidachem

Does Bidachem hold a US DMF or a CEP?
Bidachem holds 1 active US drug master file and 6 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 Bidachem FDA-registered?
One site operated by Bidachem 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 Bidachem's last inspection go?
The most recent inspection on record closed on 17 May 2024 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 7 inspections are on file.
Where does Bidachem manufacture?
2 registered sites are on record, in Italy (Fornovo San Giovanni and Italy). Every site is listed on this page with the register it came from.
What does Bidachem make?
6 molecules are on record against Bidachem, including Ambroxol, Bisacodyl, Bromhexine and Meloxicam. Each links through to that molecule's full manufacturer list.
Which regulators recognise Bidachem's GMP?
Current GMP certificates are on record from US FDA. 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 17 May 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