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