01 1Anigen Co., Ltd.
01 1HLB Pep Co., Ltd.
01 1Ganirelix acetate
01 1South Korea
Registrant Name : HLB Pep Co., Ltd.
Registration Date : 2023-10-20
Registration Number : 20231020-210-J-1554
Manufacturer Name : Anigen Co., Ltd.
Manufacturer Address : 773 Jeongjungyeon-ro, Osong-eup, Heungdeok-gu, Cheongju-si, Chungcheongbuk-do
95
PharmaCompass offers a list of Ganirelix API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Ganirelix manufacturer or Ganirelix supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Ganirelix manufacturer or Ganirelix supplier.
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, and COA 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, 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 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.
