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