01 1American Peptide Company
02 1Beckman Coulter
03 1Enteris Biopharma Inc
01 1PEPTIDE 312868 (TP508)
02 1RECOMBINANT PEPTIDE UGP302
03 1SYNTHETIC HUMAN PROINSULIN C-PEPTIDE
01 3U.S.A
01 3Inactive
01 3Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17669
Submission : 2004-09-08
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4826
Submission : 1983-02-25
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27060
Submission : 2013-07-31
Status : Inactive
Type : II
A C-Peptide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of C-Peptide, including repackagers and relabelers. The FDA regulates C-Peptide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. C-Peptide API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A C-Peptide supplier is an individual or a company that provides C-Peptide active pharmaceutical ingredient (API) or C-Peptide finished formulations upon request. The C-Peptide suppliers may include C-Peptide API manufacturers, exporters, distributors and traders.
click here to find a list of C-Peptide suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A C-Peptide DMF (Drug Master File) is a document detailing the whole manufacturing process of C-Peptide active pharmaceutical ingredient (API) in detail. Different forms of C-Peptide DMFs exist exist since differing nations have different regulations, such as C-Peptide USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A C-Peptide DMF submitted to regulatory agencies in the US is known as a USDMF. C-Peptide USDMF includes data on C-Peptide's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The C-Peptide USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of C-Peptide suppliers with USDMF on PharmaCompass.
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