01 1Lupin Ltd
01 1WARFARIN POTASSIUM
01 1India
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 31512
Submission : 2017-04-11
Status : Inactive
Type : II
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PharmaCompass offers a list of Potassium Warfarin API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Potassium Warfarin manufacturer or Potassium Warfarin supplier for your needs.
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A Potassium Warfarin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Potassium Warfarin, including repackagers and relabelers. The FDA regulates Potassium Warfarin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Potassium Warfarin 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 Potassium Warfarin supplier is an individual or a company that provides Potassium Warfarin active pharmaceutical ingredient (API) or Potassium Warfarin finished formulations upon request. The Potassium Warfarin suppliers may include Potassium Warfarin API manufacturers, exporters, distributors and traders.
click here to find a list of Potassium Warfarin suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Potassium Warfarin DMF (Drug Master File) is a document detailing the whole manufacturing process of Potassium Warfarin active pharmaceutical ingredient (API) in detail. Different forms of Potassium Warfarin DMFs exist exist since differing nations have different regulations, such as Potassium Warfarin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Potassium Warfarin DMF submitted to regulatory agencies in the US is known as a USDMF. Potassium Warfarin USDMF includes data on Potassium Warfarin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Potassium Warfarin USDMF is kept confidential to protect the manufacturer’s intellectual property.
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