01 1Esteve Quimica
01 1CIZOLIRTINE CITRATE
01 1Spain
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12820
Submission : 1998-01-16
Status : Inactive
Type : II
A Cizolirtine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Cizolirtine, including repackagers and relabelers. The FDA regulates Cizolirtine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Cizolirtine 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 Cizolirtine supplier is an individual or a company that provides Cizolirtine active pharmaceutical ingredient (API) or Cizolirtine finished formulations upon request. The Cizolirtine suppliers may include Cizolirtine API manufacturers, exporters, distributors and traders.
click here to find a list of Cizolirtine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Cizolirtine DMF (Drug Master File) is a document detailing the whole manufacturing process of Cizolirtine active pharmaceutical ingredient (API) in detail. Different forms of Cizolirtine DMFs exist exist since differing nations have different regulations, such as Cizolirtine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Cizolirtine DMF submitted to regulatory agencies in the US is known as a USDMF. Cizolirtine USDMF includes data on Cizolirtine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Cizolirtine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Cizolirtine suppliers with USDMF on PharmaCompass.
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