Bachem Group is a public, innovation-driven company specializing in the development and manufacturing of peptides and oligonucleotides.
01 1Bachem AG
02 1American Peptide Company
03 1BCN Peptides
04 1Reliable Biopharmaceutical Corporation
01 1COSYNTROPIN ACETATE
02 1COSYNTROPIN TFA SALT PEPTIDE
03 2TETRACOSACTIDE
01 1Spain
02 1Switzerland
03 2U.S.A
01 2Active
02 2Inactive
01 1Complete
02 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 : 28823
Submission : 2014-11-26
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21959
Submission : 2008-08-15
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-01-31
Pay. Date : 2013-01-11
DMF Number : 18963
Submission : 2005-11-18
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22028
Submission : 2008-09-30
Status : Inactive
Type : II
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A Synthetic ACTH manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Synthetic ACTH, including repackagers and relabelers. The FDA regulates Synthetic ACTH manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Synthetic ACTH 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 Synthetic ACTH supplier is an individual or a company that provides Synthetic ACTH active pharmaceutical ingredient (API) or Synthetic ACTH finished formulations upon request. The Synthetic ACTH suppliers may include Synthetic ACTH API manufacturers, exporters, distributors and traders.
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A Synthetic ACTH DMF (Drug Master File) is a document detailing the whole manufacturing process of Synthetic ACTH active pharmaceutical ingredient (API) in detail. Different forms of Synthetic ACTH DMFs exist exist since differing nations have different regulations, such as Synthetic ACTH USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Synthetic ACTH DMF submitted to regulatory agencies in the US is known as a USDMF. Synthetic ACTH USDMF includes data on Synthetic ACTH's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Synthetic ACTH USDMF is kept confidential to protect the manufacturer’s intellectual property.
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