01 1SIGMA TAU
01 1HYDRAZINE SULFATE (FAIRMOUNT CHEMICAL)
01 1U.S.A
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5444
Submission : 1983-10-07
Status : Inactive
Type : II
A Hydrazine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Hydrazine, including repackagers and relabelers. The FDA regulates Hydrazine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Hydrazine 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 Hydrazine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Hydrazine supplier is an individual or a company that provides Hydrazine active pharmaceutical ingredient (API) or Hydrazine finished formulations upon request. The Hydrazine suppliers may include Hydrazine API manufacturers, exporters, distributors and traders.
click here to find a list of Hydrazine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Hydrazine DMF (Drug Master File) is a document detailing the whole manufacturing process of Hydrazine active pharmaceutical ingredient (API) in detail. Different forms of Hydrazine DMFs exist exist since differing nations have different regulations, such as Hydrazine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Hydrazine DMF submitted to regulatory agencies in the US is known as a USDMF. Hydrazine USDMF includes data on Hydrazine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Hydrazine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Hydrazine suppliers with USDMF on PharmaCompass.
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