01 1Vasudha Pharma Chem
01 1CISAPRIDE MONOHYDRATE USP
01 1India
01 1Active
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 31230
Submission : 2017-01-11
Status : Active
Type : II
A Cisapride Monohydrate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Cisapride Monohydrate, including repackagers and relabelers. The FDA regulates Cisapride Monohydrate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Cisapride Monohydrate 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 Monohydrate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Cisapride Monohydrate supplier is an individual or a company that provides Cisapride Monohydrate active pharmaceutical ingredient (API) or Cisapride Monohydrate finished formulations upon request. The Cisapride Monohydrate suppliers may include Cisapride Monohydrate API manufacturers, exporters, distributors and traders.
click here to find a list of Cisapride Monohydrate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Cisapride Monohydrate DMF (Drug Master File) is a document detailing the whole manufacturing process of Cisapride Monohydrate active pharmaceutical ingredient (API) in detail. Different forms of Cisapride Monohydrate DMFs exist exist since differing nations have different regulations, such as Cisapride Monohydrate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Cisapride Monohydrate DMF submitted to regulatory agencies in the US is known as a USDMF. Cisapride Monohydrate USDMF includes data on Cisapride Monohydrate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Cisapride Monohydrate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Cisapride Monohydrate suppliers with USDMF on PharmaCompass.
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