Suppliers / Isochem

Isochem

France Updated 9 July 2026

Isochem is an API manufacturer based in France. It holds 3 active US drug master files across a filed portfolio of 3 molecules. Its GMP standing is certified by ANSM (FR).

3
active US DMFs
0
valid CEPs
2
registered plants
0
filings across 0 regulators

Registered plants

Site FDA FEI
PITHIVIERS, France Not on file
VERT LE PETIT, France Not on file

What they file, and where

Molecule Regulators Docs
Buflomedil US FDA 1
Flavoxate US FDA 1
Solifenacin Succinate US FDA 1

Also appears on these molecule pages

Flavoxate API Solifenacin API

Filings and GMP by regulator

Regulator Filings GMP certificates
ANSM (FR) None 12

Questions about Isochem

Does Isochem hold a US DMF or a CEP?
Isochem holds 3 active US drug master files. 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.
Where does Isochem manufacture?
2 registered sites are on record, in France (Pithiviers and Vert LE Petit). Every site is listed on this page with the register it came from.
What does Isochem make?
3 molecules are on record against Isochem, including Buflomedil, Flavoxate and Solifenacin Succinate. Each links through to that molecule's full manufacturer list.
Which regulators recognise Isochem's GMP?
Current GMP certificates are on record from ANSM (FR). 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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Sources on this page

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