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 2PolyPeptide Laboratories (Sweden) AB
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01 2Desmopressin
02 1Desmopressin acetate
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01 3Switzerland
Bachem Group is a public, innovation-driven company specializing in the development and manufacturing of peptides and oligonucleotides.
Registration Number : 226MF10051
Registrant's Address : 3132 Kashiwa Street, Torrance, California 90505, USA
Initial Date of Registration : 2014-02-27
Latest Date of Registration : 2014-02-27
Registration Number : 224MF10122
Registrant's Address : Ho(¨)gerudsgatan 21, Limhamn
Initial Date of Registration : 2012-07-09
Latest Date of Registration : 2023-06-28
Registration Number : 306MF10047
Registrant's Address : Ho(¨)gerudsgatan 21, Limhamn
Initial Date of Registration : 2024-03-27
Latest Date of Registration : 2024-03-27
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A DDAVP manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of DDAVP, including repackagers and relabelers. The FDA regulates DDAVP manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. DDAVP 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 DDAVP supplier is an individual or a company that provides DDAVP active pharmaceutical ingredient (API) or DDAVP finished formulations upon request. The DDAVP suppliers may include DDAVP 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 DDAVP Drug Master File in Japan (DDAVP JDMF) empowers DDAVP 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 DDAVP JDMF during the approval evaluation for pharmaceutical products. At the time of DDAVP 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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