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