01 1Johnson & Johnson Innovative Medicine
01 1CISAPRIDE(R051619) DRUG SUBSTANCE
01 1U.S.A
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11768
Submission : 1995-12-07
Status : Inactive
Type : II
13
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A Unamol manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Unamol, including repackagers and relabelers. The FDA regulates Unamol manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Unamol 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 Unamol manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Unamol supplier is an individual or a company that provides Unamol active pharmaceutical ingredient (API) or Unamol finished formulations upon request. The Unamol suppliers may include Unamol API manufacturers, exporters, distributors and traders.
click here to find a list of Unamol suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Unamol DMF (Drug Master File) is a document detailing the whole manufacturing process of Unamol active pharmaceutical ingredient (API) in detail. Different forms of Unamol DMFs exist exist since differing nations have different regulations, such as Unamol USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Unamol DMF submitted to regulatory agencies in the US is known as a USDMF. Unamol USDMF includes data on Unamol's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Unamol USDMF is kept confidential to protect the manufacturer’s intellectual property.
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