Bachem Group is a public, innovation-driven company specializing in the development and manufacturing of peptides and oligonucleotides.
01 1Bachem AG
02 1Heraeus Holding
03 1Juzen Chemical Corporation
04 1Midas Pharma
05 1Nippon Rikagaku Yakuhin
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 : 9972
Submission : 1992-11-25
Status :
Type : II
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A 08340_FLUKA manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of 08340_FLUKA, including repackagers and relabelers. The FDA regulates 08340_FLUKA manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. 08340_FLUKA 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 08340_FLUKA DMF (Drug Master File) is a document detailing the whole manufacturing process of 08340_FLUKA active pharmaceutical ingredient (API) in detail. Different forms of 08340_FLUKA DMFs exist exist since differing nations have different regulations, such as 08340_FLUKA USDMF, ASMF (EDMF), JDMF, CDMF, etc.
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