Bachem Group is a public, innovation-driven company specializing in the development and manufacturing of peptides and oligonucleotides.
01 2Bachem AG
02 1AmbioPharm
03 1Fresenius Kabi AB Brunna
04 1Fujifilm Diosynth Biotechnologies
05 2Novo Nordisk
Bachem Group is a public, innovation-driven company specializing in the development and manufacturing of peptides and oligonucleotides.
GDUFA
DMF Review : Complete
Rev. Date : 2015-05-07
Pay. Date : 2015-04-27
DMF Number : 18277
Submission : 2005-04-12
Status :
Type : II
Bachem Group is a public, innovation-driven company specializing in the development and manufacturing of peptides and oligonucleotides.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 32703
Submission : 2018-06-08
Status :
Type : II
A Glucagon manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Glucagon, including repackagers and relabelers. The FDA regulates Glucagon manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Glucagon 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 Glucagon supplier is an individual or a company that provides Glucagon active pharmaceutical ingredient (API) or Glucagon finished formulations upon request. The Glucagon suppliers may include Glucagon API manufacturers, exporters, distributors and traders.
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A Glucagon DMF (Drug Master File) is a document detailing the whole manufacturing process of Glucagon active pharmaceutical ingredient (API) in detail. Different forms of Glucagon DMFs exist exist since differing nations have different regulations, such as Glucagon USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Glucagon DMF submitted to regulatory agencies in the US is known as a USDMF. Glucagon USDMF includes data on Glucagon's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Glucagon USDMF is kept confidential to protect the manufacturer’s intellectual property.
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