In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a (1R)-2,3-Dihydro-N-2-propynl-1H-inden-1-amine methanesulfonate Drug Master File in Korea ((1R)-2,3-Dihydro-N-2-propynl-1H-inden-1-amine methanesulfonate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of (1R)-2,3-Dihydro-N-2-propynl-1H-inden-1-amine methanesulfonate. The MFDS reviews the (1R)-2,3-Dihydro-N-2-propynl-1H-inden-1-amine methanesulfonate KDMF as part of the drug registration process and uses the information provided in the (1R)-2,3-Dihydro-N-2-propynl-1H-inden-1-amine methanesulfonate KDMF to evaluate the safety and efficacy of the drug.
After submitting a (1R)-2,3-Dihydro-N-2-propynl-1H-inden-1-amine methanesulfonate 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 (1R)-2,3-Dihydro-N-2-propynl-1H-inden-1-amine methanesulfonate API can apply through the Korea Drug Master File (KDMF).
click here to find a list of (1R)-2,3-Dihydro-N-2-propynl-1H-inden-1-amine methanesulfonate suppliers with KDMF on PharmaCompass.