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