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