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