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PMC Isochem Quality system:

  • delivers the right quality to the right need in full compliance with regulatory requirement
  • is based on a long experience working​ according to the Pharmaceutical Industry and other markets guidance
  • complies ​with internal policies as well as international standards ISO and cGMP (Q7).


The 4 pillars of our Quality Policy:​

  • Regulatory compliance
  • Management Information System
  • Continuous Improvement​
  • Committed personnel


Our certifications

Certifications Gennevilliers​ Pithiviers​ Vert-Le-Petit​
ISO 9001:2015​ ♦​
cGMP (Q7)​
Inspected by FDA
ISO 14001​


PMC Isochem offers full regulatory support such as registration of new substances  through IND or ASMF/DMF filing.

More than 35 ASMF/DMF and CEP have been filed by PMC Isochem in different countries.​

See below our active Generic Files :​

​Product DMS/ASMF CEP Country
1,3,5-Trimethoxybenzene​ Italy​
Acetohydroxamic acid​ USA​, Spain
Amiodarone hydrochloride​ Australia, Canada, Europe​,  USA
Domiphen bromide​ UK, USA
Econazole nitrate​ Europe
Indoramine hydrochloride​ Ireland​,  UK, USA
Loperamide hydrochloride​ Canada, France, ​USA
Naftazone​ Belgium, France, Switzerland​
Nefopam hydrochloride​ Canada, France, ​Ireland, UK, USA
Pantoprazole sodium sesquihydrate​ Europe, USA​
Tertiobutylchlorobutyrophenone​ USA​
Tocofersolan  ( Vit. E TPGS )​   Europe, USA
Trimebutine base​ France​
Trimebutine maleate​ Canada, Europe, France, Italy, USA ​


« One of the main objectives of REACH Regulation is to increase and promote innovation by providing ​encouragement to innovate for research-orientated companies » (From ECHA November 2014 – Guidance ​on Scientific R&D (SR&D) and Product and Process Orientated Research and Development (PPORD)).​​

Deeply involved in REACH Regulation, PMC Isochem has about 60 registrations and manages close relationship with its cutomers and suppliers to ensure a reliable supply chain.  

In cooperation with France Chimie and SICOS councils, PMC Isochem also notifies intermediates manufactured under strictly controlled conditions for the protection of workers and​ the environment. ​