Regulatory

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 ISOCHEM in different countries.​

See below our active Generic Files :​

 Product​

    DMF/ASMF     

           CEP         ​

Country​

     1,3,5-Trimethoxybenzene​

♦ ​

     Italy​

     Acetohydroxamic acid​

     USA​

     Amiodarone hydrochloride​

♦ ​

     Australia, Canada, Europe​,  USA

     Diosmine​

♦ ​

♦ ​

     Europe​, Singapore, Spain,  USA

     Domiphen bromide​

     UK, USA

     Econazole nitrate​

♦ ​

     Belgium​, France, Italy, USA

     Indoramine hydrochloride​

♦ ​

     Ireland​,  UK, USA

     Loperamide hydrochloride​

♦ ​

     Canada, France, ​USA

     Naftazone​

     Belgium, France, Switzerland​

     Nefopam hydrochloride​

     Canada, France, ​UK, USA

     Nifuroxazide​

     Belgium​, France

     Pantoprazole sodium sesquihydrate​

♦ ​

     Europe, USA​

     Tertiobutylchlorobutyrophenone​

     USA​

     Tocofersolan  ( Vit. E TPGS )​

            ♦         Europe, USA

     Trimebutine base​

     France​

     Trimebutine maleate​

♦ ​

     Canada, Europe, France, Italy, USA ​

REACH

« 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, Isochem has submitted:​​

  • ~ 300 pre-registrations​

  • ~ 40 registrations available on  ECHA website ​

  • 16 PPORD ​​

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