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