01 1Sinopharm Weiqida Pharmaceutical Co., Ltd. @ [Manufacturer of Starting Material Cefuroxim]
01 1Kyungbo Pharmaceutical Co., Ltd.
01 1Cefuroxim sodium
01 1South Korea
Registrant Name : Kyungbo Pharmaceutical Co., Ltd.
Registration Date : 2019-01-02
Registration Number : 20190102-210-J-292
Manufacturer Name : Sinopharm Weiqida Pharmaceut...
Manufacturer Address : 174 Silok-ro, Asan-si, Chungcheongnam-do @ [Starting Material Cefuroxim Manufacturing...
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A Kesint manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Kesint, including repackagers and relabelers. The FDA regulates Kesint manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Kesint 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 Kesint manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Kesint supplier is an individual or a company that provides Kesint active pharmaceutical ingredient (API) or Kesint finished formulations upon request. The Kesint suppliers may include Kesint API manufacturers, exporters, distributors and traders.
click here to find a list of Kesint 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 Kesint Drug Master File in Korea (Kesint KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Kesint. The MFDS reviews the Kesint KDMF as part of the drug registration process and uses the information provided in the Kesint KDMF to evaluate the safety and efficacy of the drug.
After submitting a Kesint 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 Kesint API can apply through the Korea Drug Master File (KDMF).
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