01 1Xellia Pharmaceuticals ApS
01 1Tobramycin sulfate salt
01 1Denmark
Registration Number : 228MF10200
Registrant's Address : Dalslandsgade 11, DK-2300 Copenhagen-S, Denmark
Initial Date of Registration : 2016-10-21
Latest Date of Registration : 2016-10-21
A Tobramycin Sulfate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Tobramycin Sulfate, including repackagers and relabelers. The FDA regulates Tobramycin Sulfate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Tobramycin 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 Tobramycin Sulfate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Tobramycin Sulfate supplier is an individual or a company that provides Tobramycin Sulfate active pharmaceutical ingredient (API) or Tobramycin Sulfate finished formulations upon request. The Tobramycin Sulfate suppliers may include Tobramycin Sulfate API manufacturers, exporters, distributors and traders.
click here to find a list of Tobramycin 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 Tobramycin Sulfate Drug Master File in Japan (Tobramycin Sulfate JDMF) empowers Tobramycin 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 Tobramycin Sulfate JDMF during the approval evaluation for pharmaceutical products. At the time of Tobramycin 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 Tobramycin Sulfate suppliers with JDMF on PharmaCompass.
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