01 1Hanapharmaceutical Co., Ltd.
01 1Hanapharmaceutical Co., Ltd.
01 1flecainide acetate
01 1South Korea
Registrant Name : Hanapharmaceutical Co., Ltd.
Registration Date : 2021-03-23
Registration Number : 20210323-211-J-896
Manufacturer Name : Hanapharmaceutical Co., Ltd.
Manufacturer Address : 133, Yakjakgongdan 3-gil, Hyangnam-eup, Hwaseong-si, Gyeonggi-do
A Flecainide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Flecainide, including repackagers and relabelers. The FDA regulates Flecainide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Flecainide API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of Flecainide manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Flecainide supplier is an individual or a company that provides Flecainide active pharmaceutical ingredient (API) or Flecainide finished formulations upon request. The Flecainide suppliers may include Flecainide API manufacturers, exporters, distributors and traders.
click here to find a list of Flecainide suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Flecainide Drug Master File in Korea (Flecainide KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Flecainide. The MFDS reviews the Flecainide KDMF as part of the drug registration process and uses the information provided in the Flecainide KDMF to evaluate the safety and efficacy of the drug.
After submitting a Flecainide 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 Flecainide API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Flecainide suppliers with KDMF on PharmaCompass.
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