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