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