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