01 1Ipca Laboratories
02 1Roche Diagnostics GmbH
03 1Shanghai Ziyuan Pharmaceutical
01 3SULFADOXINE
01 1China
02 1Germany
03 1India
01 3Inactive
01 3Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22910
Submission : 2009-08-10
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16512
Submission : 2003-03-21
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17809
Submission : 2004-11-03
Status : Inactive
Type : II
A Sulfadoxine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Sulfadoxine, including repackagers and relabelers. The FDA regulates Sulfadoxine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Sulfadoxine 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 Sulfadoxine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Sulfadoxine supplier is an individual or a company that provides Sulfadoxine active pharmaceutical ingredient (API) or Sulfadoxine finished formulations upon request. The Sulfadoxine suppliers may include Sulfadoxine API manufacturers, exporters, distributors and traders.
click here to find a list of Sulfadoxine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Sulfadoxine DMF (Drug Master File) is a document detailing the whole manufacturing process of Sulfadoxine active pharmaceutical ingredient (API) in detail. Different forms of Sulfadoxine DMFs exist exist since differing nations have different regulations, such as Sulfadoxine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Sulfadoxine DMF submitted to regulatory agencies in the US is known as a USDMF. Sulfadoxine USDMF includes data on Sulfadoxine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Sulfadoxine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Sulfadoxine suppliers with USDMF on PharmaCompass.
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