Bachem Group is a public, innovation-driven company specializing in the development and manufacturing of peptides and oligonucleotides.
01 1Bachem AG
02 1Biovectra Inc
03 1Ferring Pharmaceuticals
04 1Fujifilm Diosynth Biotechnologies
05 1Mallinckrodt Pharmaceuticals
06 3Peninsula Laboratories
07 1PolyPeptide Group
08 1Salk Institute
09 3Blank
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 : 11078
Submission : 1994-09-10
Status :
Type : II
A Adrenocorticotropic Hormone manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Adrenocorticotropic Hormone, including repackagers and relabelers. The FDA regulates Adrenocorticotropic Hormone manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Adrenocorticotropic Hormone 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 Adrenocorticotropic Hormone supplier is an individual or a company that provides Adrenocorticotropic Hormone active pharmaceutical ingredient (API) or Adrenocorticotropic Hormone finished formulations upon request. The Adrenocorticotropic Hormone suppliers may include Adrenocorticotropic Hormone API manufacturers, exporters, distributors and traders.
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A Adrenocorticotropic Hormone DMF (Drug Master File) is a document detailing the whole manufacturing process of Adrenocorticotropic Hormone active pharmaceutical ingredient (API) in detail. Different forms of Adrenocorticotropic Hormone DMFs exist exist since differing nations have different regulations, such as Adrenocorticotropic Hormone USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Adrenocorticotropic Hormone DMF submitted to regulatory agencies in the US is known as a USDMF. Adrenocorticotropic Hormone USDMF includes data on Adrenocorticotropic Hormone's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Adrenocorticotropic Hormone USDMF is kept confidential to protect the manufacturer’s intellectual property.
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