01 2Xellia Pharmaceuticals ApS
01 1Polymyxin B sulfate salt
02 1Polymyxin B sulfate sterile
01 2Denmark
Registration Number : 219MF10071
Registrant's Address : Dalslandsgade 11, DK-2300 Copenhagen-S, Denmark
Initial Date of Registration : 2007-03-14
Latest Date of Registration : 2007-03-14
Registration Number : 218MF10934
Registrant's Address : Dalslandsgade 11, DK-2300 Copenhagen-S, Denmark
Initial Date of Registration : 2006-11-21
Latest Date of Registration : 2006-11-21
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.
The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.
The Polymyxin B Sulfate Drug Master File in Japan (Polymyxin B Sulfate JDMF) empowers Polymyxin B Sulfate API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).
PMDA reviews the Polymyxin B Sulfate JDMF during the approval evaluation for pharmaceutical products. At the time of Polymyxin B Sulfate JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
click here to find a list of Polymyxin B Sulfate suppliers with JDMF on PharmaCompass.
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