01 1Lunan Pharmaceutical
01 1MOSAPRIDE CITRATE (NON-STERILE BULK FORM)
01 1China
01 1Active
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19425
Submission : 2006-04-20
Status : Active
Type : II
A Mosapride Citrate Dihydrate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Mosapride Citrate Dihydrate, including repackagers and relabelers. The FDA regulates Mosapride Citrate Dihydrate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Mosapride Citrate Dihydrate 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 Mosapride Citrate Dihydrate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Mosapride Citrate Dihydrate supplier is an individual or a company that provides Mosapride Citrate Dihydrate active pharmaceutical ingredient (API) or Mosapride Citrate Dihydrate finished formulations upon request. The Mosapride Citrate Dihydrate suppliers may include Mosapride Citrate Dihydrate API manufacturers, exporters, distributors and traders.
click here to find a list of Mosapride Citrate Dihydrate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Mosapride Citrate Dihydrate DMF (Drug Master File) is a document detailing the whole manufacturing process of Mosapride Citrate Dihydrate active pharmaceutical ingredient (API) in detail. Different forms of Mosapride Citrate Dihydrate DMFs exist exist since differing nations have different regulations, such as Mosapride Citrate Dihydrate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Mosapride Citrate Dihydrate DMF submitted to regulatory agencies in the US is known as a USDMF. Mosapride Citrate Dihydrate USDMF includes data on Mosapride Citrate Dihydrate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Mosapride Citrate Dihydrate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Mosapride Citrate Dihydrate suppliers with USDMF on PharmaCompass.
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