Quality Assurance
Drug Master File (DMF) and Certificate of Suitability to the Monographs of the European Pharmacopoeia (CEP)
"Drug master file (DMF or ASMF)" is a file containing information about a drug's manufacturing process and quality, registered in advance with regulatory authorities. Using this file facilitates efficient application for approval in the relevant country.
The status of our DMF registrations for active pharmaceutical ingredients is as follows:
Japan
Japanese Pharmacopoeia: L-Tyrosine
Japanese Pharmacopoeia: Acetylcysteine
Japanese Pharmacopoeia: L-Cysteine
Japanese Pharmacopoeia: Ibudilast
Extramural Regulations: Cysteine Malate
Extramural Regulations: L-Ethyltyrosine Hydrochloride
USA
Acetylcysteine USP
L-Tyrosine USP
Europe (CEP*)
Tyrosine EP
Acetylcysteine EP
*CEP: Certificate of Suitability to the Monographs of the European Pharmacopeia
This certificate is inspected and issued by the European Directorate for the Quality of Medicines & Healthcare (EDQM) for products that fall under the category of preparations or compounds listed in the European Pharmacopoeia (EP), and indicates that the product complies with the requirements of the EP. It can be used as documentation for approval applications in some countries, including EU member states and other regions.
China
Acetylcysteine
Taiwan
Acetylcysteine JP
L-Cysteine JP
- L-cysteine (Egypt, Indonesia)
- Acetylcysteine (Korea, Indonesia)
- Ibuprofen piconol (Korea)
- L-tyrosine (Egypt, Korea)