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01 1Kyungbo Pharmaceutical Co., Ltd.
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01 1Kyungbo Pharmaceutical Co., Ltd.
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01 1Belotecan (CKD-602)
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01 1South Korea
Registrant Name : Kyungbo Pharmaceutical Co., Ltd.
Registration Date : 2023-11-01
Registration Number : 1673-54-ND
Manufacturer Name : Kyungbo Pharmaceutical Co., ...
Manufacturer Address : 174 Silok-ro, Asan-si, Chungcheongnam-do
A Belotecan manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Belotecan, including repackagers and relabelers. The FDA regulates Belotecan manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Belotecan 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 Belotecan manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Belotecan supplier is an individual or a company that provides Belotecan active pharmaceutical ingredient (API) or Belotecan finished formulations upon request. The Belotecan suppliers may include Belotecan API manufacturers, exporters, distributors and traders.
click here to find a list of Belotecan 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 Belotecan Drug Master File in Korea (Belotecan KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Belotecan. The MFDS reviews the Belotecan KDMF as part of the drug registration process and uses the information provided in the Belotecan KDMF to evaluate the safety and efficacy of the drug.
After submitting a Belotecan 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 Belotecan API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Belotecan suppliers with KDMF on PharmaCompass.
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