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