01 1Anygen Inc.
01 1Anygen Inc.
01 1Ganirelix acetate
01 1South Korea
Registrant Name : Anygen Inc.
Registration Date : 2023-10-20
Registration Number : 20231020-210-J-1554
Manufacturer Name : Anygen Inc.
Manufacturer Address : 773 Jeongjungyeonje-ro, Osong-eup, Heungdeok-gu, Cheongju-si, Chungcheongbuk-do
A Ganirelix manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ganirelix, including repackagers and relabelers. The FDA regulates Ganirelix manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ganirelix 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 Ganirelix manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Ganirelix supplier is an individual or a company that provides Ganirelix active pharmaceutical ingredient (API) or Ganirelix finished formulations upon request. The Ganirelix suppliers may include Ganirelix API manufacturers, exporters, distributors and traders.
click here to find a list of Ganirelix 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 Ganirelix Drug Master File in Korea (Ganirelix KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Ganirelix. The MFDS reviews the Ganirelix KDMF as part of the drug registration process and uses the information provided in the Ganirelix KDMF to evaluate the safety and efficacy of the drug.
After submitting a Ganirelix 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 Ganirelix API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Ganirelix suppliers with KDMF on PharmaCompass.
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