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