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