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