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