01 1Fresenius Kabi iPSUM S. r. l.
01 1Bacampicillin Hydrochloride
01 1U.S.A
Registration Number : 221MF10291
Registrant's Address : via Roma, n. 108 20060 Cassina de' Pecchi (MI), Italy
Initial Date of Registration : 2009-12-25
Latest Date of Registration : 2009-12-25
A Bacampicillin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Bacampicillin, including repackagers and relabelers. The FDA regulates Bacampicillin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Bacampicillin 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 Bacampicillin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Bacampicillin supplier is an individual or a company that provides Bacampicillin active pharmaceutical ingredient (API) or Bacampicillin finished formulations upon request. The Bacampicillin suppliers may include Bacampicillin API manufacturers, exporters, distributors and traders.
click here to find a list of Bacampicillin 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 Bacampicillin Drug Master File in Japan (Bacampicillin JDMF) empowers Bacampicillin 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 Bacampicillin JDMF during the approval evaluation for pharmaceutical products. At the time of Bacampicillin 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 Bacampicillin suppliers with JDMF on PharmaCompass.
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