01 1CHEMO IBERICA SA
02 1Magle Chemoswed
03 1Sai Life Sciences Limited
04 1Solara Active Pharma Sciences
05 1Sun Pharmaceutical Industries Limited
06 1Yangzhou Pharmaceutical
01 2ISRADIPINE
02 1ISRADIPINE (USP26)
03 1ISRADIPINE UPS
04 1ISRADIPINE, USP
05 1Isradipine USP
01 1China
02 3India
03 1Spain
04 1Sweden
01 4Active
02 2Inactive
01 1Complete
02 5Blank
GDUFA
DMF Review : Complete
Rev. Date : 2014-10-10
Pay. Date : 2014-03-20
DMF Number : 17367
Submission : 2004-05-05
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19376
Submission : 2006-04-19
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21013
Submission : 2007-10-29
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16369
Submission : 2003-01-21
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17873
Submission : 2004-12-07
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17384
Submission : 2004-05-17
Status : Active
Type : II
A Isradipine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Isradipine, including repackagers and relabelers. The FDA regulates Isradipine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Isradipine 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 Isradipine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Isradipine supplier is an individual or a company that provides Isradipine active pharmaceutical ingredient (API) or Isradipine finished formulations upon request. The Isradipine suppliers may include Isradipine API manufacturers, exporters, distributors and traders.
click here to find a list of Isradipine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Isradipine DMF (Drug Master File) is a document detailing the whole manufacturing process of Isradipine active pharmaceutical ingredient (API) in detail. Different forms of Isradipine DMFs exist exist since differing nations have different regulations, such as Isradipine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Isradipine DMF submitted to regulatory agencies in the US is known as a USDMF. Isradipine USDMF includes data on Isradipine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Isradipine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Isradipine suppliers with USDMF on PharmaCompass.
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