01 2Xellia Pharmaceuticals ApS
01 1Aging Life Science Co., Ltd.
02 1Novartis Korea Ltd.
01 2Polymyxin B sulfate
01 2Denmark
Registrant Name : Novartis Korea Ltd.
Registration Date : 2023-08-11
Registration Number : 20210317-211-J-890(A)
Manufacturer Name : Xellia Pharmaceuticals ApS
Manufacturer Address : Dalslandsgade 11, 2300 Copenhagen S, Denmark
Registrant Name : Aging Life Science Co., Ltd.
Registration Date : 2021-03-17
Registration Number : 20210317-211-J-890
Manufacturer Name : Xellia Pharmaceuticals ApS
Manufacturer Address : Dalslandsgade 11 2300 Copenhagen S.
A Polymyxin B Sulfate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Polymyxin B Sulfate, including repackagers and relabelers. The FDA regulates Polymyxin B Sulfate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Polymyxin B Sulfate 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 Polymyxin B Sulfate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Polymyxin B Sulfate supplier is an individual or a company that provides Polymyxin B Sulfate active pharmaceutical ingredient (API) or Polymyxin B Sulfate finished formulations upon request. The Polymyxin B Sulfate suppliers may include Polymyxin B Sulfate API manufacturers, exporters, distributors and traders.
click here to find a list of Polymyxin B Sulfate 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 Polymyxin B Sulfate Drug Master File in Korea (Polymyxin B Sulfate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Polymyxin B Sulfate. The MFDS reviews the Polymyxin B Sulfate KDMF as part of the drug registration process and uses the information provided in the Polymyxin B Sulfate KDMF to evaluate the safety and efficacy of the drug.
After submitting a Polymyxin B Sulfate 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 Polymyxin B Sulfate API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Polymyxin B Sulfate suppliers with KDMF on PharmaCompass.
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