01 1Xinjiang Nuziline Bio-Pharmaceutical Co., Ltd.
01 1Darim Biotech Co., Ltd.
01 1Conjugated estrogen
01 1China
Registrant Name : Darim Biotech Co., Ltd.
Registration Date : 2021-06-11
Registration Number : 20210611-209-J-1024
Manufacturer Name : Xinjiang Nuziline Bio-Pharma...
Manufacturer Address : 252 km, 218 State Road, Xinjiang, China, 835800
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A Cenestin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Cenestin, including repackagers and relabelers. The FDA regulates Cenestin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Cenestin 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 Cenestin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Cenestin supplier is an individual or a company that provides Cenestin active pharmaceutical ingredient (API) or Cenestin finished formulations upon request. The Cenestin suppliers may include Cenestin API manufacturers, exporters, distributors and traders.
click here to find a list of Cenestin 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 Cenestin Drug Master File in Korea (Cenestin KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Cenestin. The MFDS reviews the Cenestin KDMF as part of the drug registration process and uses the information provided in the Cenestin KDMF to evaluate the safety and efficacy of the drug.
After submitting a Cenestin 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 Cenestin API can apply through the Korea Drug Master File (KDMF).
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