01 1Hunan Jiudian Hongyang Pharmaceutical.Co.,Ltd
01 1Ace Biopharm Co., Ltd.
01 1Dioctyl sodium sulfosuccinate
01 1China
Registrant Name : Ace Biopharm Co., Ltd.
Registration Date : 2022-12-15
Registration Number : 20221215-211-J-1422
Manufacturer Name : Hunan Jiudian Hongyang Pharm...
Manufacturer Address : Tongguan Circular Economy Industrial base, Wangcheng Economic and Technological Devel...
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A Sobital manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Sobital, including repackagers and relabelers. The FDA regulates Sobital manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Sobital 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 Sobital manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Sobital supplier is an individual or a company that provides Sobital active pharmaceutical ingredient (API) or Sobital finished formulations upon request. The Sobital suppliers may include Sobital API manufacturers, exporters, distributors and traders.
click here to find a list of Sobital 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 Sobital Drug Master File in Korea (Sobital KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Sobital. The MFDS reviews the Sobital KDMF as part of the drug registration process and uses the information provided in the Sobital KDMF to evaluate the safety and efficacy of the drug.
After submitting a Sobital 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 Sobital API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Sobital suppliers with KDMF on PharmaCompass.
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