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