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