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