01 1Cadila Pharmaceuticals
01 1ITOPRIDE HYDROCHLORIDE
01 1India
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21190
Submission : 2007-11-28
Status : Inactive
Type : II
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A Ganaton manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ganaton, including repackagers and relabelers. The FDA regulates Ganaton manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ganaton 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 Ganaton manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Ganaton supplier is an individual or a company that provides Ganaton active pharmaceutical ingredient (API) or Ganaton finished formulations upon request. The Ganaton suppliers may include Ganaton API manufacturers, exporters, distributors and traders.
click here to find a list of Ganaton suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Ganaton DMF (Drug Master File) is a document detailing the whole manufacturing process of Ganaton active pharmaceutical ingredient (API) in detail. Different forms of Ganaton DMFs exist exist since differing nations have different regulations, such as Ganaton USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Ganaton DMF submitted to regulatory agencies in the US is known as a USDMF. Ganaton USDMF includes data on Ganaton's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Ganaton USDMF is kept confidential to protect the manufacturer’s intellectual property.
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