01 1Atul Bioscience Ltd
01 1CLIOQUINOL
01 1India
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9078
Submission : 1991-04-20
Status : Inactive
Type : II
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A Iodo manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Iodo, including repackagers and relabelers. The FDA regulates Iodo manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Iodo 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 Iodo manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Iodo supplier is an individual or a company that provides Iodo active pharmaceutical ingredient (API) or Iodo finished formulations upon request. The Iodo suppliers may include Iodo API manufacturers, exporters, distributors and traders.
click here to find a list of Iodo suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Iodo DMF (Drug Master File) is a document detailing the whole manufacturing process of Iodo active pharmaceutical ingredient (API) in detail. Different forms of Iodo DMFs exist exist since differing nations have different regulations, such as Iodo USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Iodo DMF submitted to regulatory agencies in the US is known as a USDMF. Iodo USDMF includes data on Iodo's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Iodo USDMF is kept confidential to protect the manufacturer’s intellectual property.
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