Bachem Group is a public, innovation-driven company specializing in the development and manufacturing of peptides and oligonucleotides.
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01 1Bachem Americas, Inc.
02 1BCN Peptides S. A.
03 1ILS Inc.
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01 1Elcatonin
02 1Elcatonin
03 1Salmon calcitonin "Ito"
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01 1Spain
02 1Switzerland
03 1U.S.A
Bachem Group is a public, innovation-driven company specializing in the development and manufacturing of peptides and oligonucleotides.
Registration Number : 218MF10953
Registrant's Address : 3132 Kashiwa Street, Torrance, California 90505, USA
Initial Date of Registration : 2006-11-24
Latest Date of Registration : 2006-11-24
Registration Number : 223MF10073
Registrant's Address : Poligono industrial Els Vinyets-Els Fogars. Sector II 08777-Sant Quinti de Mediona, B...
Initial Date of Registration : 2011-05-27
Latest Date of Registration : 2015-08-03
Registration Number : 218MF10773
Registrant's Address : 2-1 Kubogaoka 1-chome, Moriya City, Ibaraki Prefecture
Initial Date of Registration : 2006-09-22
Latest Date of Registration : 2009-03-26
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A Fortical manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Fortical, including repackagers and relabelers. The FDA regulates Fortical manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Fortical 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 Fortical supplier is an individual or a company that provides Fortical active pharmaceutical ingredient (API) or Fortical finished formulations upon request. The Fortical suppliers may include Fortical API manufacturers, exporters, distributors and traders.
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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 Fortical Drug Master File in Japan (Fortical JDMF) empowers Fortical API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).
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