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