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