01 1AIR PRODUCTS FR 38070 Saint Quentin Fallavier
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01 1PHENOLPHTHALEIN
02 1YELLOW PHENOLPHTHALEIN
01 1France
02 1Blank
01 2Inactive
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GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 2472
Submission : 1975-06-13
Status : Inactive
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 7748
Submission : 1988-10-25
Status : Inactive
Type : II
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A Phenolphthalein manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Phenolphthalein, including repackagers and relabelers. The FDA regulates Phenolphthalein manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Phenolphthalein 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 Phenolphthalein manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Phenolphthalein supplier is an individual or a company that provides Phenolphthalein active pharmaceutical ingredient (API) or Phenolphthalein finished formulations upon request. The Phenolphthalein suppliers may include Phenolphthalein API manufacturers, exporters, distributors and traders.
click here to find a list of Phenolphthalein suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Phenolphthalein DMF (Drug Master File) is a document detailing the whole manufacturing process of Phenolphthalein active pharmaceutical ingredient (API) in detail. Different forms of Phenolphthalein DMFs exist exist since differing nations have different regulations, such as Phenolphthalein USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Phenolphthalein DMF submitted to regulatory agencies in the US is known as a USDMF. Phenolphthalein USDMF includes data on Phenolphthalein's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Phenolphthalein USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Phenolphthalein suppliers with USDMF on PharmaCompass.
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