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