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01 1QUINIDINE BISULFATE
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01 1Inactive
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USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5090
Submission : 1983-07-20
Status : Inactive
Type : II
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A Quinidine Bisulfate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Quinidine Bisulfate, including repackagers and relabelers. The FDA regulates Quinidine Bisulfate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Quinidine Bisulfate 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 Quinidine Bisulfate supplier is an individual or a company that provides Quinidine Bisulfate active pharmaceutical ingredient (API) or Quinidine Bisulfate finished formulations upon request. The Quinidine Bisulfate suppliers may include Quinidine Bisulfate API manufacturers, exporters, distributors and traders.
click here to find a list of Quinidine Bisulfate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Quinidine Bisulfate DMF (Drug Master File) is a document detailing the whole manufacturing process of Quinidine Bisulfate active pharmaceutical ingredient (API) in detail. Different forms of Quinidine Bisulfate DMFs exist exist since differing nations have different regulations, such as Quinidine Bisulfate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Quinidine Bisulfate DMF submitted to regulatory agencies in the US is known as a USDMF. Quinidine Bisulfate USDMF includes data on Quinidine Bisulfate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Quinidine Bisulfate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Quinidine Bisulfate suppliers with USDMF on PharmaCompass.
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