Bachem Group is a public, innovation-driven company specializing in the development and manufacturing of peptides and oligonucleotides.
01 1Bachem AG
01 1Squid ibant acetate
01 1Switzerland
Bachem Group is a public, innovation-driven company specializing in the development and manufacturing of peptides and oligonucleotides.
Registration Number : 229MF10071
Registrant's Address : Hauptstrasse 144,4416 Bubendorf Switzerland
Initial Date of Registration : 2017-04-04
Latest Date of Registration : 2018-09-03
A Icatibant manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Icatibant, including repackagers and relabelers. The FDA regulates Icatibant manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Icatibant API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A Icatibant supplier is an individual or a company that provides Icatibant active pharmaceutical ingredient (API) or Icatibant finished formulations upon request. The Icatibant suppliers may include Icatibant API manufacturers, exporters, distributors and traders.
click here to find a list of Icatibant 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 Icatibant Drug Master File in Japan (Icatibant JDMF) empowers Icatibant 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 Icatibant JDMF during the approval evaluation for pharmaceutical products. At the time of Icatibant JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
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