01 1Apotex Pharmachem
02 1Aurisco Pharmaceutical
03 1Hetero Drugs
04 2Industriale Chimica
05 1MSN Laboratories
06 1Zhejiang Shenzhou Pharmaceutical
01 3EPLERENONE
02 1EPLERENONE API
03 1EPLERENONE MEK HEMISOLVATE (1:0.5)
04 1EPLERENONE PH. EUR.
05 1EPLERENONE [ROUTE CODE: PL]
01 1Canada
02 2China
03 2India
04 2Italy
01 6Active
02 1Inactive
01 4Complete
02 3Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19796
Submission : 2006-09-25
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2015-10-30
Pay. Date : 2013-12-02
DMF Number : 27672
Submission : 2013-12-25
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2019-10-16
Pay. Date : 2019-09-24
DMF Number : 33832
Submission : 2019-05-20
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2019-04-15
Pay. Date : 2019-01-29
DMF Number : 32998
Submission : 2018-11-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19715
Submission : 2006-09-08
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-03-14
Pay. Date : 2013-12-04
DMF Number : 23466
Submission : 2010-01-20
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37024
Submission : 2022-07-13
Status : Active
Type : II
A Eplerenone manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Eplerenone, including repackagers and relabelers. The FDA regulates Eplerenone manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Eplerenone 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 Eplerenone manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Eplerenone supplier is an individual or a company that provides Eplerenone active pharmaceutical ingredient (API) or Eplerenone finished formulations upon request. The Eplerenone suppliers may include Eplerenone API manufacturers, exporters, distributors and traders.
click here to find a list of Eplerenone suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Eplerenone DMF (Drug Master File) is a document detailing the whole manufacturing process of Eplerenone active pharmaceutical ingredient (API) in detail. Different forms of Eplerenone DMFs exist exist since differing nations have different regulations, such as Eplerenone USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Eplerenone DMF submitted to regulatory agencies in the US is known as a USDMF. Eplerenone USDMF includes data on Eplerenone's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Eplerenone USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Eplerenone suppliers with USDMF on PharmaCompass.
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