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