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