01 1Dishman Carbogen Amcis
01 1HEXETIDINE
01 1India
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24162
Submission : 2010-09-07
Status : Inactive
Type : II
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A Bactidol manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Bactidol, including repackagers and relabelers. The FDA regulates Bactidol manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Bactidol 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 Bactidol supplier is an individual or a company that provides Bactidol active pharmaceutical ingredient (API) or Bactidol finished formulations upon request. The Bactidol suppliers may include Bactidol API manufacturers, exporters, distributors and traders.
click here to find a list of Bactidol suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Bactidol DMF (Drug Master File) is a document detailing the whole manufacturing process of Bactidol active pharmaceutical ingredient (API) in detail. Different forms of Bactidol DMFs exist exist since differing nations have different regulations, such as Bactidol USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Bactidol DMF submitted to regulatory agencies in the US is known as a USDMF. Bactidol USDMF includes data on Bactidol's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Bactidol USDMF is kept confidential to protect the manufacturer’s intellectual property.
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