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