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01 2XYLITOL
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USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 8316
Submission : 1989-12-07
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 : 2711
Submission : 1976-07-09
Status : Inactive
Type : IV
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
A Ribitol manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ribitol, including repackagers and relabelers. The FDA regulates Ribitol manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ribitol 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 Ribitol manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Ribitol supplier is an individual or a company that provides Ribitol active pharmaceutical ingredient (API) or Ribitol finished formulations upon request. The Ribitol suppliers may include Ribitol API manufacturers, exporters, distributors and traders.
click here to find a list of Ribitol suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Ribitol DMF (Drug Master File) is a document detailing the whole manufacturing process of Ribitol active pharmaceutical ingredient (API) in detail. Different forms of Ribitol DMFs exist exist since differing nations have different regulations, such as Ribitol USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Ribitol DMF submitted to regulatory agencies in the US is known as a USDMF. Ribitol USDMF includes data on Ribitol's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Ribitol USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Ribitol suppliers with USDMF on PharmaCompass.
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