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