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