01 1Curia
02 1Minsheng Group Shaoxing Pharmaceutical
03 1Stragen Pharma SA
04 1TAIHUA NATURAL PLANT PHARMACEUTICAL CO., LTD.
01 2HOMOHARRINGTONINE
02 1OMACETAXINE MEPESUCCINATE
03 1OMACETAXINE MEPESUCCINATE (HOMOHARRINGTONINE)
01 2China
02 1Switzerland
03 1U.S.A
01 3Active
02 1Inactive
01 2Complete
02 2Blank
GDUFA
DMF Review : Complete
Rev. Date : 2016-12-22
Pay. Date : 2016-08-24
DMF Number : 30463
Submission : 2016-08-31
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2016-07-28
Pay. Date : 2016-02-24
DMF Number : 30158
Submission : 2015-12-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20542
Submission : 2007-06-26
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 30550
Submission : 2016-05-03
Status : Active
Type : II
A OMACETAXINE MEPESUCCINATE manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of OMACETAXINE MEPESUCCINATE, including repackagers and relabelers. The FDA regulates OMACETAXINE MEPESUCCINATE manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. OMACETAXINE MEPESUCCINATE API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A OMACETAXINE MEPESUCCINATE supplier is an individual or a company that provides OMACETAXINE MEPESUCCINATE active pharmaceutical ingredient (API) or OMACETAXINE MEPESUCCINATE finished formulations upon request. The OMACETAXINE MEPESUCCINATE suppliers may include OMACETAXINE MEPESUCCINATE API manufacturers, exporters, distributors and traders.
click here to find a list of OMACETAXINE MEPESUCCINATE suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A OMACETAXINE MEPESUCCINATE DMF (Drug Master File) is a document detailing the whole manufacturing process of OMACETAXINE MEPESUCCINATE active pharmaceutical ingredient (API) in detail. Different forms of OMACETAXINE MEPESUCCINATE DMFs exist exist since differing nations have different regulations, such as OMACETAXINE MEPESUCCINATE USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A OMACETAXINE MEPESUCCINATE DMF submitted to regulatory agencies in the US is known as a USDMF. OMACETAXINE MEPESUCCINATE USDMF includes data on OMACETAXINE MEPESUCCINATE's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The OMACETAXINE MEPESUCCINATE USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of OMACETAXINE MEPESUCCINATE suppliers with USDMF on PharmaCompass.
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