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