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