01 1SIGMA TAU
01 1INOSINE
01 1U.S.A
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 7687
Submission : 1988-09-15
Status : Inactive
Type : II
A Inosine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Inosine, including repackagers and relabelers. The FDA regulates Inosine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Inosine 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 Inosine supplier is an individual or a company that provides Inosine active pharmaceutical ingredient (API) or Inosine finished formulations upon request. The Inosine suppliers may include Inosine API manufacturers, exporters, distributors and traders.
click here to find a list of Inosine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Inosine DMF (Drug Master File) is a document detailing the whole manufacturing process of Inosine active pharmaceutical ingredient (API) in detail. Different forms of Inosine DMFs exist exist since differing nations have different regulations, such as Inosine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Inosine DMF submitted to regulatory agencies in the US is known as a USDMF. Inosine USDMF includes data on Inosine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Inosine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Inosine suppliers with USDMF on PharmaCompass.
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