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01 1RIBAVARIN, USP
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01 1Inactive
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USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15108
Submission : 2000-10-24
Status : Inactive
Type : II
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A Ribavarin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ribavarin, including repackagers and relabelers. The FDA regulates Ribavarin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ribavarin 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 Ribavarin supplier is an individual or a company that provides Ribavarin active pharmaceutical ingredient (API) or Ribavarin finished formulations upon request. The Ribavarin suppliers may include Ribavarin API manufacturers, exporters, distributors and traders.
click here to find a list of Ribavarin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Ribavarin DMF (Drug Master File) is a document detailing the whole manufacturing process of Ribavarin active pharmaceutical ingredient (API) in detail. Different forms of Ribavarin DMFs exist exist since differing nations have different regulations, such as Ribavarin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Ribavarin DMF submitted to regulatory agencies in the US is known as a USDMF. Ribavarin USDMF includes data on Ribavarin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Ribavarin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Ribavarin suppliers with USDMF on PharmaCompass.
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