Rusan Pharma: Over 30 years of specializing in the treatment of Addiction and Pain Management.
01 1Rusan Pharma
02 1Lonza Group
03 1ScinoPharm Taiwan Ltd
01 1DL-2-(DIFLUOROMETHYL) ORNITHINE MONOHYDROCHLORIDE MONOHYDRATE
02 1EFLORNITHINE HYDROCHLORIDE
03 1EFLORNITHINE HYDROCHLORIDE MONOHYDRATE
01 1India
02 1Switzerland
03 1Taiwan
01 2Active
02 1Inactive
01 3Blank
Rusan Pharma: Over 30 years of specializing in the treatment of Addiction and Pain Management.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 31780
Submission : 2017-06-29
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11932
Submission : 1996-04-17
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18509
Submission : 2005-07-12
Status : Active
Type : II
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A alpha Difluoromethylornithine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of alpha Difluoromethylornithine, including repackagers and relabelers. The FDA regulates alpha Difluoromethylornithine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. alpha Difluoromethylornithine API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A alpha Difluoromethylornithine supplier is an individual or a company that provides alpha Difluoromethylornithine active pharmaceutical ingredient (API) or alpha Difluoromethylornithine finished formulations upon request. The alpha Difluoromethylornithine suppliers may include alpha Difluoromethylornithine API manufacturers, exporters, distributors and traders.
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A alpha Difluoromethylornithine DMF (Drug Master File) is a document detailing the whole manufacturing process of alpha Difluoromethylornithine active pharmaceutical ingredient (API) in detail. Different forms of alpha Difluoromethylornithine DMFs exist exist since differing nations have different regulations, such as alpha Difluoromethylornithine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A alpha Difluoromethylornithine DMF submitted to regulatory agencies in the US is known as a USDMF. alpha Difluoromethylornithine USDMF includes data on alpha Difluoromethylornithine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The alpha Difluoromethylornithine USDMF is kept confidential to protect the manufacturer’s intellectual property.
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