01 1Latina Pharma S. p. A.
01 1Aztreonam
01 1Germany
Registration Number : 219MF10225
Registrant's Address : VIA MURILLO, 7, 04013-SERMONETA (LATINA), ITALY
Initial Date of Registration : 2007-07-06
Latest Date of Registration : 2007-07-06
A Aztreonam manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Aztreonam, including repackagers and relabelers. The FDA regulates Aztreonam manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Aztreonam 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 Aztreonam manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Aztreonam supplier is an individual or a company that provides Aztreonam active pharmaceutical ingredient (API) or Aztreonam finished formulations upon request. The Aztreonam suppliers may include Aztreonam API manufacturers, exporters, distributors and traders.
click here to find a list of Aztreonam 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 Aztreonam Drug Master File in Japan (Aztreonam JDMF) empowers Aztreonam 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 Aztreonam JDMF during the approval evaluation for pharmaceutical products. At the time of Aztreonam 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 Aztreonam suppliers with JDMF on PharmaCompass.
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