01 1Curia
02 1Formosa Laboratories
03 1Naari
04 1Qinhuangdao Zizhu Pharmaceutical
05 1Zhejiang Xianju Junye Pharmaceutical Co. LTD
06 1Zhejiang Xianju Pharmaceutical Co. Ltd
01 5MIFEPRISTONE
02 1MIFEPRISTONE MICRONIZED
01 3China
02 1India
03 1Taiwan
04 1U.S.A
01 5Active
02 1Inactive
01 2Complete
02 4Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37250
Submission : 2022-06-28
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2016-05-24
Pay. Date : 2013-09-12
DMF Number : 27474
Submission : 2013-09-13
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37121
Submission : 2022-05-12
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24628
Submission : 2011-01-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21944
Submission : 2008-09-08
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-11-16
Pay. Date : 2017-08-21
DMF Number : 31873
Submission : 2017-07-20
Status : Active
Type : II
A Mifepristone manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Mifepristone, including repackagers and relabelers. The FDA regulates Mifepristone manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Mifepristone 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 Mifepristone manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Mifepristone supplier is an individual or a company that provides Mifepristone active pharmaceutical ingredient (API) or Mifepristone finished formulations upon request. The Mifepristone suppliers may include Mifepristone API manufacturers, exporters, distributors and traders.
click here to find a list of Mifepristone suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Mifepristone DMF (Drug Master File) is a document detailing the whole manufacturing process of Mifepristone active pharmaceutical ingredient (API) in detail. Different forms of Mifepristone DMFs exist exist since differing nations have different regulations, such as Mifepristone USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Mifepristone DMF submitted to regulatory agencies in the US is known as a USDMF. Mifepristone USDMF includes data on Mifepristone's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Mifepristone USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Mifepristone suppliers with USDMF on PharmaCompass.
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