Bachem Group is a public, innovation-driven company specializing in the development and manufacturing of peptides and oligonucleotides.
01 1Bachem SA, Succursale de Vionnaz
02 1Curia Italy S. r. l.
03 2Dong Kook Pharmaceutical Co. , Ltd.
04 1SI Group, Inc.
01 5Propofol
01 2South Korea
02 1Switzerland
03 2U.S.A
Bachem Group is a public, innovation-driven company specializing in the development and manufacturing of peptides and oligonucleotides.
Registration Number : 221MF10007
Registrant's Address : Route du simplon 22, CH-1895 Vionnaz-Switzerland
Initial Date of Registration : 2009-01-13
Latest Date of Registration : 2013-03-14
Registration Number : 218MF10529
Registrant's Address : Via del Vecchio Politecnico n. 9, 20121 Milano (MI) - Italy
Initial Date of Registration : 2006-05-18
Latest Date of Registration : 2013-04-23
Registration Number : 219MF10087
Registrant's Address : #997-8, Daechi-3 Dong, Gennam Gu, Seoul, Korea
Initial Date of Registration : 2007-03-14
Latest Date of Registration : 2007-03-14
Registration Number : 223MF10043
Registrant's Address : 715, Yeongdong-daero, Gangnam-gu, Seoul, Korea
Initial Date of Registration : 2011-03-11
Latest Date of Registration : 2011-03-11
Registration Number : 218MF10683
Registrant's Address : 1790 Hughes Landing Blvd Suite 600, The Woodlands, TX 77380 US
Initial Date of Registration : 2006-08-11
Latest Date of Registration : 2017-09-08
A DIPRIVAN manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of DIPRIVAN, including repackagers and relabelers. The FDA regulates DIPRIVAN manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. DIPRIVAN 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 DIPRIVAN supplier is an individual or a company that provides DIPRIVAN active pharmaceutical ingredient (API) or DIPRIVAN finished formulations upon request. The DIPRIVAN suppliers may include DIPRIVAN 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 DIPRIVAN Drug Master File in Japan (DIPRIVAN JDMF) empowers DIPRIVAN 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 DIPRIVAN JDMF during the approval evaluation for pharmaceutical products. At the time of DIPRIVAN 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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