In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a n,n-dimethyl-2-(1-phenyl-1-pyridin-2-ylethoxy)ethanamine butanedioate Drug Master File in Korea (n,n-dimethyl-2-(1-phenyl-1-pyridin-2-ylethoxy)ethanamine butanedioate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of n,n-dimethyl-2-(1-phenyl-1-pyridin-2-ylethoxy)ethanamine butanedioate. The MFDS reviews the n,n-dimethyl-2-(1-phenyl-1-pyridin-2-ylethoxy)ethanamine butanedioate KDMF as part of the drug registration process and uses the information provided in the n,n-dimethyl-2-(1-phenyl-1-pyridin-2-ylethoxy)ethanamine butanedioate KDMF to evaluate the safety and efficacy of the drug.
After submitting a n,n-dimethyl-2-(1-phenyl-1-pyridin-2-ylethoxy)ethanamine butanedioate 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 n,n-dimethyl-2-(1-phenyl-1-pyridin-2-ylethoxy)ethanamine butanedioate API can apply through the Korea Drug Master File (KDMF).
click here to find a list of n,n-dimethyl-2-(1-phenyl-1-pyridin-2-ylethoxy)ethanamine butanedioate suppliers with KDMF on PharmaCompass.