01 1Corden Pharma Bergamo S.p.A
02 1Blank
01 1GUANETHIDINE MONOSULFATE
02 1GUANETHIDINE SULFATE, USP
01 1Italy
02 1Blank
01 2Inactive
01 2Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5122
Submission : 1983-08-26
Status : Inactive
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5070
Submission : 1983-07-26
Status : Inactive
Type : II
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A Guanethidine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Guanethidine, including repackagers and relabelers. The FDA regulates Guanethidine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Guanethidine 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 Guanethidine supplier is an individual or a company that provides Guanethidine active pharmaceutical ingredient (API) or Guanethidine finished formulations upon request. The Guanethidine suppliers may include Guanethidine API manufacturers, exporters, distributors and traders.
click here to find a list of Guanethidine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Guanethidine DMF (Drug Master File) is a document detailing the whole manufacturing process of Guanethidine active pharmaceutical ingredient (API) in detail. Different forms of Guanethidine DMFs exist exist since differing nations have different regulations, such as Guanethidine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Guanethidine DMF submitted to regulatory agencies in the US is known as a USDMF. Guanethidine USDMF includes data on Guanethidine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Guanethidine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Guanethidine suppliers with USDMF on PharmaCompass.
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