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