01 1Dongbang FTL Co., Ltd.
01 1Dongbang FTL Co., Ltd.
01 1Mephenamic acid
01 1South Korea
Registrant Name : Dongbang FTL Co., Ltd.
Registration Date : 2019-02-22
Registration Number : 20190222-211-J-312
Manufacturer Name : Dongbang FTL Co., Ltd.
Manufacturer Address : 78, Yakjakgongdan 4-gil, Hyangnam-eup, Hwaseong-si, Gyeonggi-do
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A Parkemed manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Parkemed, including repackagers and relabelers. The FDA regulates Parkemed manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Parkemed API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A Parkemed supplier is an individual or a company that provides Parkemed active pharmaceutical ingredient (API) or Parkemed finished formulations upon request. The Parkemed suppliers may include Parkemed API manufacturers, exporters, distributors and traders.
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In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Parkemed Drug Master File in Korea (Parkemed KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Parkemed. The MFDS reviews the Parkemed KDMF as part of the drug registration process and uses the information provided in the Parkemed KDMF to evaluate the safety and efficacy of the drug.
After submitting a Parkemed 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 Parkemed API can apply through the Korea Drug Master File (KDMF).
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