01 1Bayer AG@Bayer AG
01 1Bayer Korea Ltd.
01 1Cyproterone acetate
01 1Germany
Registrant Name : Bayer Korea Ltd.
Registration Date : 2021-08-10
Registration Number : 20210810-209-J-1087
Manufacturer Name : Bayer AG@Bayer AG
Manufacturer Address : Ernst-Schering-Straβe 14, 59192 Bergkamen, Germany@Max-Dohrn-Straβe 8, Drug Substan...
A Cyproterone Acetate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Cyproterone Acetate, including repackagers and relabelers. The FDA regulates Cyproterone Acetate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Cyproterone Acetate 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 Cyproterone Acetate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Cyproterone Acetate supplier is an individual or a company that provides Cyproterone Acetate active pharmaceutical ingredient (API) or Cyproterone Acetate finished formulations upon request. The Cyproterone Acetate suppliers may include Cyproterone Acetate API manufacturers, exporters, distributors and traders.
click here to find a list of Cyproterone Acetate 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 Cyproterone Acetate Drug Master File in Korea (Cyproterone Acetate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Cyproterone Acetate. The MFDS reviews the Cyproterone Acetate KDMF as part of the drug registration process and uses the information provided in the Cyproterone Acetate KDMF to evaluate the safety and efficacy of the drug.
After submitting a Cyproterone Acetate 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 Cyproterone Acetate API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Cyproterone Acetate suppliers with KDMF on PharmaCompass.
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