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