01 1YS Life Science Co., Ltd. @ [Starting material 'Naltrexone hydrochloride' manufacturing plant]
01 1YS Life Science Co., Ltd.
01 1Nalfurafine hydrochloride
01 1South Korea
Registrant Name : YS Life Science Co., Ltd.
Registration Date : 2019-01-17
Registration Number : 20190117-211-J-305
Manufacturer Name : YS Life Science Co., Ltd. @ ...
Manufacturer Address : 207, Sujeong-ro, Jangan-myeon, Hwaseong-si, Gyeonggi-do @ [Starting material 'Naltrex...
A Nalfurafine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Nalfurafine, including repackagers and relabelers. The FDA regulates Nalfurafine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Nalfurafine 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 Nalfurafine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Nalfurafine supplier is an individual or a company that provides Nalfurafine active pharmaceutical ingredient (API) or Nalfurafine finished formulations upon request. The Nalfurafine suppliers may include Nalfurafine API manufacturers, exporters, distributors and traders.
click here to find a list of Nalfurafine 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 Nalfurafine Drug Master File in Korea (Nalfurafine KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Nalfurafine. The MFDS reviews the Nalfurafine KDMF as part of the drug registration process and uses the information provided in the Nalfurafine KDMF to evaluate the safety and efficacy of the drug.
After submitting a Nalfurafine 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 Nalfurafine API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Nalfurafine suppliers with KDMF on PharmaCompass.
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