01 1Alembic Pharmaceuticals Limited
02 1Beijing Huikang Boyuan Chemical Tech
03 1Bionpharma
04 1Fuxin Long Rui Pharmaceutical
05 1Hetero Drugs
06 1Jiangsu Hengrui Medicine
07 1Maithri Drugs
08 1Servier
09 1Urquima S.A. Grupo Uriach
10 1Zhejiang Liaoyuan Pharmaceutical Co LTD
11 1Zydus Lifesciences
01 9IVABRADINE HYDROCHLORIDE
02 1IVABRADINE HYDROCHLORIDE (FORM IV)
03 1IVABRADINE MONOSULFATE
01 4China
02 1France
03 4India
04 1Spain
05 1U.S.A
01 10Active
02 1Inactive
01 6Complete
02 5Blank
GDUFA
DMF Review : Complete
Rev. Date : 2020-08-12
Pay. Date : 2020-07-22
DMF Number : 32074
Submission : 2017-09-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 28658
Submission : 2014-09-29
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2018-11-05
Pay. Date : 2018-09-21
DMF Number : 33077
Submission : 2018-09-21
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33377
Submission : 2018-12-14
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2019-02-04
Pay. Date : 2018-12-04
DMF Number : 33368
Submission : 2018-12-12
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2019-04-17
Pay. Date : 2019-03-19
DMF Number : 33246
Submission : 2018-10-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27979
Submission : 2014-03-14
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2019-03-01
Pay. Date : 2018-10-19
DMF Number : 33213
Submission : 2018-10-15
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 32616
Submission : 2019-10-23
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2019-01-29
Pay. Date : 2018-11-26
DMF Number : 33107
Submission : 2018-10-31
Status : Active
Type : II
A Ivabradine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ivabradine, including repackagers and relabelers. The FDA regulates Ivabradine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ivabradine 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 Ivabradine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Ivabradine supplier is an individual or a company that provides Ivabradine active pharmaceutical ingredient (API) or Ivabradine finished formulations upon request. The Ivabradine suppliers may include Ivabradine API manufacturers, exporters, distributors and traders.
click here to find a list of Ivabradine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Ivabradine DMF (Drug Master File) is a document detailing the whole manufacturing process of Ivabradine active pharmaceutical ingredient (API) in detail. Different forms of Ivabradine DMFs exist exist since differing nations have different regulations, such as Ivabradine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Ivabradine DMF submitted to regulatory agencies in the US is known as a USDMF. Ivabradine USDMF includes data on Ivabradine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Ivabradine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Ivabradine suppliers with USDMF on PharmaCompass.
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