01 1Dongbang FTL Co., Ltd.
01 1Dongbang FTL Co., Ltd.
01 1Mepenam Mountain
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, Jeyakgongdan 4-gil, Hyangnam-eup, Hwaseong-si, Gyeonggi-do
82
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A Mefenamic acid [USAN:INN:BAN:JAN] manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Mefenamic acid [USAN:INN:BAN:JAN], including repackagers and relabelers. The FDA regulates Mefenamic acid [USAN:INN:BAN:JAN] manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Mefenamic acid [USAN:INN:BAN:JAN] 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 Mefenamic acid [USAN:INN:BAN:JAN] supplier is an individual or a company that provides Mefenamic acid [USAN:INN:BAN:JAN] active pharmaceutical ingredient (API) or Mefenamic acid [USAN:INN:BAN:JAN] finished formulations upon request. The Mefenamic acid [USAN:INN:BAN:JAN] suppliers may include Mefenamic acid [USAN:INN:BAN:JAN] 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 Mefenamic acid [USAN:INN:BAN:JAN] Drug Master File in Korea (Mefenamic acid [USAN:INN:BAN:JAN] KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Mefenamic acid [USAN:INN:BAN:JAN]. The MFDS reviews the Mefenamic acid [USAN:INN:BAN:JAN] KDMF as part of the drug registration process and uses the information provided in the Mefenamic acid [USAN:INN:BAN:JAN] KDMF to evaluate the safety and efficacy of the drug.
After submitting a Mefenamic acid [USAN:INN:BAN:JAN] 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 Mefenamic acid [USAN:INN:BAN:JAN] API can apply through the Korea Drug Master File (KDMF).
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