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