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