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