01 1SIGMA TAU
02 1Blank
01 1ANTIPYRINE
02 1ANTIPYRINE AS PRODUCED IN THE ST. LOUIS, MISSOURI PLANT
01 1U.S.A
02 1Blank
01 2Inactive
01 2Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4836
Submission : 1983-03-04
Status : Inactive
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5940
Submission : 1985-07-25
Status : Inactive
Type : II
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A Phenazon manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Phenazon, including repackagers and relabelers. The FDA regulates Phenazon manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Phenazon 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 Phenazon manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Phenazon supplier is an individual or a company that provides Phenazon active pharmaceutical ingredient (API) or Phenazon finished formulations upon request. The Phenazon suppliers may include Phenazon API manufacturers, exporters, distributors and traders.
click here to find a list of Phenazon suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Phenazon DMF (Drug Master File) is a document detailing the whole manufacturing process of Phenazon active pharmaceutical ingredient (API) in detail. Different forms of Phenazon DMFs exist exist since differing nations have different regulations, such as Phenazon USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Phenazon DMF submitted to regulatory agencies in the US is known as a USDMF. Phenazon USDMF includes data on Phenazon's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Phenazon USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Phenazon suppliers with USDMF on PharmaCompass.
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