01 1Ipca Laboratories
01 1AMODIAQUINE HYDROCHLORIDE USP
01 1India
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22216
Submission : 2009-02-23
Status : Inactive
Type : II
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A Camoquine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Camoquine, including repackagers and relabelers. The FDA regulates Camoquine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Camoquine 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 Camoquine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Camoquine supplier is an individual or a company that provides Camoquine active pharmaceutical ingredient (API) or Camoquine finished formulations upon request. The Camoquine suppliers may include Camoquine API manufacturers, exporters, distributors and traders.
click here to find a list of Camoquine suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Camoquine DMF (Drug Master File) is a document detailing the whole manufacturing process of Camoquine active pharmaceutical ingredient (API) in detail. Different forms of Camoquine DMFs exist exist since differing nations have different regulations, such as Camoquine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Camoquine DMF submitted to regulatory agencies in the US is known as a USDMF. Camoquine USDMF includes data on Camoquine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Camoquine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Camoquine suppliers with USDMF on PharmaCompass.
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