01 1Samjin Pharmaceutical Co., Ltd. @Nanyang Tianhua Pharmaceutical Co., Ltd.
01 1Samjin Pharmaceutical Co., Ltd.
01 1Betanechol chloride
01 1South Korea
Registrant Name : Samjin Pharmaceutical Co., Ltd.
Registration Date : 2019-05-23
Registration Number : 20190523-209-J-350
Manufacturer Name : Samjin Pharmaceutical Co., L...
Manufacturer Address : 156, Osongsaengmyeong 6-ro, Osong-eup, Heungdeok-gu, Cheongju-si, Chungcheongbuk-do @...
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A Uro-Carb manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Uro-Carb, including repackagers and relabelers. The FDA regulates Uro-Carb manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Uro-Carb 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 Uro-Carb manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Uro-Carb supplier is an individual or a company that provides Uro-Carb active pharmaceutical ingredient (API) or Uro-Carb finished formulations upon request. The Uro-Carb suppliers may include Uro-Carb API manufacturers, exporters, distributors and traders.
click here to find a list of Uro-Carb 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 Uro-Carb Drug Master File in Korea (Uro-Carb KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Uro-Carb. The MFDS reviews the Uro-Carb KDMF as part of the drug registration process and uses the information provided in the Uro-Carb KDMF to evaluate the safety and efficacy of the drug.
After submitting a Uro-Carb 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 Uro-Carb API can apply through the Korea Drug Master File (KDMF).
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