In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a PW-2132 Drug Master File in Korea (PW-2132 KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of PW-2132. The MFDS reviews the PW-2132 KDMF as part of the drug registration process and uses the information provided in the PW-2132 KDMF to evaluate the safety and efficacy of the drug.
After submitting a PW-2132 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 PW-2132 API can apply through the Korea Drug Master File (KDMF).
click here to find a list of PW-2132 suppliers with KDMF on PharmaCompass.