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