01 1Nycomed Austria GmbH
01 1LORNOXICAM
01 1Austria
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16755
Submission : 2003-08-07
Status : Inactive
Type : II
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A Xefo manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Xefo, including repackagers and relabelers. The FDA regulates Xefo manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Xefo 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 Xefo manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Xefo supplier is an individual or a company that provides Xefo active pharmaceutical ingredient (API) or Xefo finished formulations upon request. The Xefo suppliers may include Xefo API manufacturers, exporters, distributors and traders.
click here to find a list of Xefo suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Xefo DMF (Drug Master File) is a document detailing the whole manufacturing process of Xefo active pharmaceutical ingredient (API) in detail. Different forms of Xefo DMFs exist exist since differing nations have different regulations, such as Xefo USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Xefo DMF submitted to regulatory agencies in the US is known as a USDMF. Xefo USDMF includes data on Xefo's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Xefo USDMF is kept confidential to protect the manufacturer’s intellectual property.
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