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
A Premarin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Premarin, including repackagers and relabelers. The FDA regulates Premarin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Premarin 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 Premarin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Premarin supplier is an individual or a company that provides Premarin active pharmaceutical ingredient (API) or Premarin finished formulations upon request. The Premarin suppliers may include Premarin API manufacturers, exporters, distributors and traders.
click here to find a list of Premarin 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 Premarin Drug Master File in Korea (Premarin KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Premarin. The MFDS reviews the Premarin KDMF as part of the drug registration process and uses the information provided in the Premarin KDMF to evaluate the safety and efficacy of the drug.
After submitting a Premarin 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 Premarin API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Premarin suppliers with KDMF on PharmaCompass.
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