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01 1TAPI Hungary Industries Ltd.
01 1Tobramycin "Teva"
01 1Israel
Registration Number : 219MF10146
Registrant's Address : 13 Pallagi u(´)t, Debrecen, 4042-Hungary
Initial Date of Registration : 2007-04-27
Latest Date of Registration : 2023-07-12
A Tobramycin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Tobramycin, including repackagers and relabelers. The FDA regulates Tobramycin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Tobramycin 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 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Tobramycin supplier is an individual or a company that provides Tobramycin active pharmaceutical ingredient (API) or Tobramycin finished formulations upon request. The Tobramycin suppliers may include Tobramycin API manufacturers, exporters, distributors and traders.
click here to find a list of Tobramycin 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 Drug Master File in Japan (Tobramycin JDMF) empowers Tobramycin 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 JDMF during the approval evaluation for pharmaceutical products. At the time of Tobramycin 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 suppliers with JDMF on PharmaCompass.
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