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