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01 1TOLONIUM CHLORIDE (TOLUIDINE BLUE-O)
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01 1Inactive
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USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10382
Submission : 1993-07-22
Status : Inactive
Type : II
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A M-Cresol manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of M-Cresol, including repackagers and relabelers. The FDA regulates M-Cresol manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. M-Cresol 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 M-Cresol manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A M-Cresol supplier is an individual or a company that provides M-Cresol active pharmaceutical ingredient (API) or M-Cresol finished formulations upon request. The M-Cresol suppliers may include M-Cresol API manufacturers, exporters, distributors and traders.
click here to find a list of M-Cresol suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A M-Cresol DMF (Drug Master File) is a document detailing the whole manufacturing process of M-Cresol active pharmaceutical ingredient (API) in detail. Different forms of M-Cresol DMFs exist exist since differing nations have different regulations, such as M-Cresol USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A M-Cresol DMF submitted to regulatory agencies in the US is known as a USDMF. M-Cresol USDMF includes data on M-Cresol's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The M-Cresol USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of M-Cresol suppliers with USDMF on PharmaCompass.
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