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