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