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