01 1HL Genomics Co., Ltd.
01 1HL Genomics Co., Ltd.
01 1Indocyanine green
01 1South Korea
Registrant Name : HL Genomics Co., Ltd.
Registration Date : 2019-10-23
Registration Number : 20191023-210-J-461
Manufacturer Name : HL Genomics Co., Ltd.
Manufacturer Address : 1552 Bogaewonsam-ro, Wonsam-myeon, Cheoin-gu, Yongin-si, Gyeonggi-do
93
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A ICG manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of ICG, including repackagers and relabelers. The FDA regulates ICG manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. ICG 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 ICG manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A ICG supplier is an individual or a company that provides ICG active pharmaceutical ingredient (API) or ICG finished formulations upon request. The ICG suppliers may include ICG API manufacturers, exporters, distributors and traders.
click here to find a list of ICG 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 ICG Drug Master File in Korea (ICG KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of ICG. The MFDS reviews the ICG KDMF as part of the drug registration process and uses the information provided in the ICG KDMF to evaluate the safety and efficacy of the drug.
After submitting a ICG 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 ICG API can apply through the Korea Drug Master File (KDMF).
click here to find a list of ICG suppliers with KDMF on PharmaCompass.
