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USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 6559
Submission : 1986-08-29
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 6163
Submission : 1985-11-21
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 6134
Submission : 1985-12-16
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
A Tolrestat manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Tolrestat, including repackagers and relabelers. The FDA regulates Tolrestat manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Tolrestat 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 Tolrestat supplier is an individual or a company that provides Tolrestat active pharmaceutical ingredient (API) or Tolrestat finished formulations upon request. The Tolrestat suppliers may include Tolrestat API manufacturers, exporters, distributors and traders.
click here to find a list of Tolrestat suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Tolrestat DMF (Drug Master File) is a document detailing the whole manufacturing process of Tolrestat active pharmaceutical ingredient (API) in detail. Different forms of Tolrestat DMFs exist exist since differing nations have different regulations, such as Tolrestat USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Tolrestat DMF submitted to regulatory agencies in the US is known as a USDMF. Tolrestat USDMF includes data on Tolrestat's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Tolrestat USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Tolrestat suppliers with USDMF on PharmaCompass.
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