In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a 13-cis-retinoic acid,Isotretinoin Drug Master File in Korea (13-cis-retinoic acid,Isotretinoin KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of 13-cis-retinoic acid,Isotretinoin. The MFDS reviews the 13-cis-retinoic acid,Isotretinoin KDMF as part of the drug registration process and uses the information provided in the 13-cis-retinoic acid,Isotretinoin KDMF to evaluate the safety and efficacy of the drug.
After submitting a 13-cis-retinoic acid,Isotretinoin KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their 13-cis-retinoic acid,Isotretinoin API can apply through the Korea Drug Master File (KDMF).
click here to find a list of 13-cis-retinoic acid,Isotretinoin suppliers with KDMF on PharmaCompass.