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01 1SULFAGUANIDINE
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01 1Inactive
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USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 2484
Submission : 1975-07-03
Status : Inactive
Type : II
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A Sulfaguanidine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Sulfaguanidine, including repackagers and relabelers. The FDA regulates Sulfaguanidine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Sulfaguanidine 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 Sulfaguanidine supplier is an individual or a company that provides Sulfaguanidine active pharmaceutical ingredient (API) or Sulfaguanidine finished formulations upon request. The Sulfaguanidine suppliers may include Sulfaguanidine API manufacturers, exporters, distributors and traders.
click here to find a list of Sulfaguanidine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Sulfaguanidine DMF (Drug Master File) is a document detailing the whole manufacturing process of Sulfaguanidine active pharmaceutical ingredient (API) in detail. Different forms of Sulfaguanidine DMFs exist exist since differing nations have different regulations, such as Sulfaguanidine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Sulfaguanidine DMF submitted to regulatory agencies in the US is known as a USDMF. Sulfaguanidine USDMF includes data on Sulfaguanidine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Sulfaguanidine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Sulfaguanidine suppliers with USDMF on PharmaCompass.
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