01 1Bracco
01 1IOPANOIC ACID USP
01 1Italy
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5409
Submission : 1984-05-23
Status : Inactive
Type : II
57
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A Cistobil manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Cistobil, including repackagers and relabelers. The FDA regulates Cistobil manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Cistobil 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 Cistobil supplier is an individual or a company that provides Cistobil active pharmaceutical ingredient (API) or Cistobil finished formulations upon request. The Cistobil suppliers may include Cistobil API manufacturers, exporters, distributors and traders.
click here to find a list of Cistobil suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Cistobil DMF (Drug Master File) is a document detailing the whole manufacturing process of Cistobil active pharmaceutical ingredient (API) in detail. Different forms of Cistobil DMFs exist exist since differing nations have different regulations, such as Cistobil USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Cistobil DMF submitted to regulatory agencies in the US is known as a USDMF. Cistobil USDMF includes data on Cistobil's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Cistobil USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Cistobil suppliers with USDMF on PharmaCompass.
