01 1Regis Technologies
02 1SAFC
03 1The Dow Chemical Company
01 2AMINOGUANIDINE HYDROCHLORIDE
02 1AMINOGUANIDINE HYDROCHLORIDE (W176-2)
01 3U.S.A
01 3Inactive
01 3Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 8045
Submission : 1989-04-27
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 6757
Submission : 1986-12-31
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9306
Submission : 1991-08-26
Status : Inactive
Type : II
A GUANIDINE HYDROCHLORIDE API manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of GUANIDINE HYDROCHLORIDE API, including repackagers and relabelers. The FDA regulates GUANIDINE HYDROCHLORIDE API manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. GUANIDINE HYDROCHLORIDE API API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of GUANIDINE HYDROCHLORIDE API manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A GUANIDINE HYDROCHLORIDE API supplier is an individual or a company that provides GUANIDINE HYDROCHLORIDE API active pharmaceutical ingredient (API) or GUANIDINE HYDROCHLORIDE API finished formulations upon request. The GUANIDINE HYDROCHLORIDE API suppliers may include GUANIDINE HYDROCHLORIDE API API manufacturers, exporters, distributors and traders.
click here to find a list of GUANIDINE HYDROCHLORIDE API suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A GUANIDINE HYDROCHLORIDE API DMF (Drug Master File) is a document detailing the whole manufacturing process of GUANIDINE HYDROCHLORIDE API active pharmaceutical ingredient (API) in detail. Different forms of GUANIDINE HYDROCHLORIDE API DMFs exist exist since differing nations have different regulations, such as GUANIDINE HYDROCHLORIDE API USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A GUANIDINE HYDROCHLORIDE API DMF submitted to regulatory agencies in the US is known as a USDMF. GUANIDINE HYDROCHLORIDE API USDMF includes data on GUANIDINE HYDROCHLORIDE API's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The GUANIDINE HYDROCHLORIDE API USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of GUANIDINE HYDROCHLORIDE API suppliers with USDMF on PharmaCompass.
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