Bachem Group is a public, innovation-driven company specializing in the development and manufacturing of peptides and oligonucleotides.
01 1Bachem Americas, Inc.
02 1Hamari PFST Co., Ltd.
03 1Polypeptide Laboratories, Inc.
01 1Teriparatide Acetate
02 2Teriparatide acetate
01 1Japan
02 2Switzerland
Bachem Group is a public, innovation-driven company specializing in the development and manufacturing of peptides and oligonucleotides.
Registration Number : 228MF10213
Registrant's Address : 3132 Kashiwa Street, Torrance, California 90505, USA
Initial Date of Registration : 2016-11-09
Latest Date of Registration : 2016-11-09
Registration Number : 231MF10059
Registrant's Address : Osaka Prefecture, Osaka City, Suminoe Ward, Nanko Kita 1-19-40
Initial Date of Registration : 2019-02-25
Latest Date of Registration : 2023-03-15
Registration Number : 230MF10022
Registrant's Address : 365 Maple Avenue, Torrance, CA 90503, U.S. S. A
Initial Date of Registration : 2018-02-14
Latest Date of Registration : 2018-02-14
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A Forteo manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Forteo, including repackagers and relabelers. The FDA regulates Forteo manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Forteo 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 Forteo supplier is an individual or a company that provides Forteo active pharmaceutical ingredient (API) or Forteo finished formulations upon request. The Forteo suppliers may include Forteo 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 Forteo Drug Master File in Japan (Forteo JDMF) empowers Forteo 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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