01 1GSK
02 1Blank
01 1DIPHENYLPYRALINE (THIS DMF FORMERLY HELD BY NOPCO CHEM. CO)
02 1DIPHENYLPYRALINE HCL--PRODUCED IN SMITHKLINE FACILS-CONSHOHOCKEN, PA.
01 1United Kingdom
02 1Blank
01 2Inactive
01 2Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4997
Submission : 1983-07-08
Status : Inactive
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 80
Submission : 1951-10-18
Status : Inactive
Type : II
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A Diphenylpyraline manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Diphenylpyraline, including repackagers and relabelers. The FDA regulates Diphenylpyraline manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Diphenylpyraline 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 Diphenylpyraline supplier is an individual or a company that provides Diphenylpyraline active pharmaceutical ingredient (API) or Diphenylpyraline finished formulations upon request. The Diphenylpyraline suppliers may include Diphenylpyraline API manufacturers, exporters, distributors and traders.
click here to find a list of Diphenylpyraline suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Diphenylpyraline DMF (Drug Master File) is a document detailing the whole manufacturing process of Diphenylpyraline active pharmaceutical ingredient (API) in detail. Different forms of Diphenylpyraline DMFs exist exist since differing nations have different regulations, such as Diphenylpyraline USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Diphenylpyraline DMF submitted to regulatory agencies in the US is known as a USDMF. Diphenylpyraline USDMF includes data on Diphenylpyraline's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Diphenylpyraline USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Diphenylpyraline suppliers with USDMF on PharmaCompass.
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