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