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