Bachem Group is a public, innovation-driven company specializing in the development and manufacturing of peptides and oligonucleotides.
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01 1Bachem AG
02 1Heraeus Holding
03 1Juzen Chemical Corporation
04 1Midas Pharma
05 1Nippon Rikagaku Yakuhin
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01 35-AMINOLEVULINIC ACID HYDROCHLORIDE
02 15-AMINOLEVULINIC ACID HYDROCHLORIDE DRUG SUBSTANCE
03 1STUDY RESIDUE PROBLS RELATED TO U/OF EXPERIMENTAL ORGANOPHOSPHORUS COM
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01 2Germany
02 2Japan
03 1Switzerland
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01 3Active
02 2Inactive
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01 5Blank
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 : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24359
Submission : 2010-11-12
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17844
Submission : 2004-11-15
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 29376
Submission : 2015-05-27
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23711
Submission : 2010-04-06
Status : Inactive
Type : II
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A AlaCare manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of AlaCare, including repackagers and relabelers. The FDA regulates AlaCare manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. AlaCare 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 AlaCare DMF (Drug Master File) is a document detailing the whole manufacturing process of AlaCare active pharmaceutical ingredient (API) in detail. Different forms of AlaCare DMFs exist exist since differing nations have different regulations, such as AlaCare USDMF, ASMF (EDMF), JDMF, CDMF, etc.
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