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