In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Regitin methanesulphonate Drug Master File in Korea (Regitin methanesulphonate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Regitin methanesulphonate. The MFDS reviews the Regitin methanesulphonate KDMF as part of the drug registration process and uses the information provided in the Regitin methanesulphonate KDMF to evaluate the safety and efficacy of the drug.
After submitting a Regitin methanesulphonate 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 Regitin methanesulphonate API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Regitin methanesulphonate suppliers with KDMF on PharmaCompass.