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