Biocodex

France Updated 9 July 2026

Biocodex is a finished-dose manufacturer based in France. It appears in 299 regulatory filings across 28 regulators, without an active US DMF or CEP on file. Its filings concentrate with EMA, ANSM (FR) and FDA (GH). Its GMP standing is certified by ANSM (FR), MFDS (Korea) and ANVISA (Brazil), among 5 authorities. Its most recent recorded inspection, by US FDA, closed on 17 June 2022 as VAI.

active US DMFs

valid CEPs

registered plants 2 with an FDA FEI number

299

filings across 28 regulators

These figures were checked against the regulators' own files on 25 July 2026

Plants

2 of 2 confirmed

Inspections

3 of 3 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

17 June 2022 VAI US FDA
23 January 2020 VAI US FDA
16 September 2016 NAI US FDA

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

Registered plants

Site	FDA FEI
Beauvais, United Arab Emirates	Not on file
BEAUVAIS, France	Not on file
France, France	3003346516
NOUACEUR, Morocco	Not on file
avenue Blaise Pascal 60 Beauvais France, Nigeria	Not on file
Montijo, Portugal	Not on file

2 further sites are on record.

Filings and GMP by regulator

Regulator	Filings	GMP certificates
EMA	47	1
ANSM (FR)	28	25
FDA (GH)	26	None
AIFA (IT)	23	None
FAMHP (BE)	22	None
URPL (PL)	18	None
MFDS (Korea)	None	2
ANVISA (Brazil)	None	2
NAFDAC (NG)	None	2

Scale

Year	Revenue	Exports	Destinations
2024	$543.1M	Not reported	Not reported

Export figures are customs aggregates. We do not publish the identity of any buyer. Revenue shown in US dollars, converted from the reported currency.

Questions about Biocodex

Does Biocodex hold a US DMF or a CEP?

No active US drug master file or valid CEP is on record for Biocodex. It does have 299 filings with 28 regulators, so it is registered, just not with the two strong registers buyers usually screen on.

Is Biocodex FDA-registered?

2 sites operated by Biocodex 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 Biocodex's last inspection go?

The most recent inspection on record closed on 17 June 2022 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 3 inspections are on file.

Where does Biocodex manufacture?

8 registered sites are on record, in United Arab Emirates, France, Morocco and Nigeria (Beauvais, Beauvais and France among others). Every site is listed on this page with the register it came from.

Which regulators recognise Biocodex's GMP?

Current GMP certificates are on record from ANSM (FR), MFDS (Korea), ANVISA (Brazil), NAFDAC (NG) and EMA. 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 June 2022.

Comparable suppliers

AdhexPharma also in France Advanced Accelerator Applications also in France Aspen Notre Dame De Bondeville also in France Astrazeneca Dunkerque Production also in France Astrea Fontaine also in France

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
Company filings: Revenue as reported