01 1Hanseo Chem Co., Ltd.
02 1Kukjeon Pharmaceutical Co., Ltd.
01 1Gukjeon Co., Ltd.
02 1Hanseo Chem Co., Ltd.
01 2Tianeptine sodium
01 2South Korea
Registrant Name : Hanseo Chem Co., Ltd.
Registration Date : 2019-10-02
Registration Number : 20191002-211-J-441
Manufacturer Name : Hanseo Chem Co., Ltd.
Manufacturer Address : 41 Poseunggongdan-ro, Poseung-eup, Pyeongtaek-si, Gyeonggi-do
Registrant Name : Gukjeon Co., Ltd.
Registration Date : 2018-11-06
Registration Number : 20181106-211-J-115
Manufacturer Name : Kukjeon Pharmaceutical Co., ...
Manufacturer Address : 8, Balan Gongdan-ro, Hyangnam-eup, Hwaseong-si, Gyeonggi-do
97
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A Stablon;Coaxil;Tatinol manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Stablon;Coaxil;Tatinol, including repackagers and relabelers. The FDA regulates Stablon;Coaxil;Tatinol manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Stablon;Coaxil;Tatinol 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 Stablon;Coaxil;Tatinol supplier is an individual or a company that provides Stablon;Coaxil;Tatinol active pharmaceutical ingredient (API) or Stablon;Coaxil;Tatinol finished formulations upon request. The Stablon;Coaxil;Tatinol suppliers may include Stablon;Coaxil;Tatinol API manufacturers, exporters, distributors and traders.
click here to find a list of Stablon;Coaxil;Tatinol suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA 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 Stablon;Coaxil;Tatinol Drug Master File in Korea (Stablon;Coaxil;Tatinol KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Stablon;Coaxil;Tatinol. The MFDS reviews the Stablon;Coaxil;Tatinol KDMF as part of the drug registration process and uses the information provided in the Stablon;Coaxil;Tatinol KDMF to evaluate the safety and efficacy of the drug.
After submitting a Stablon;Coaxil;Tatinol 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 Stablon;Coaxil;Tatinol API can apply through the Korea Drug Master File (KDMF).
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