01 1Cambrex Corporation
02 1DOTTIKON EXCLUSIVE SYNTHESIS AG
03 1Dipharma
04 1Kremers Urban Pharmaceuticals
05 4Lunan Pharmaceutical
06 1NORDIC SYNTHESIS AB
07 1Shandong Keyuan Pharmaceutical
08 2Blank
01 1DILUTED ISOSORBIDE MONONITRATE
02 1DILUTED ISOSORBIDE MONONITRATE (60%)
03 1DILUTED ISOSORBIDE MONONITRATE (70%)
04 1DILUTED ISOSORBIDE MONONITRATE (DRUG SUBSTANCE, NON-STERILE)
05 1DILUTED ISOSORBIDE MONONITRATE USP
06 1ISOSORBIDE 5-MONONITRATE (5-ISM)
07 1ISOSORBIDE MONONITRATE (NON-STERILE, BULK FORM)
08 1ISOSORBIDE-2-MONONITRATE
09 1ISOSORBIDE-2-MONONITRATE (2-ISMN)
10 1ISOSORBIDE-5-MONONITRATE
11 1ISOSORBIDE-5-MONONITRATE (5-ISMN)
12 1ISOSORBIDE-5-MONONITRATE/LACTOSE
01 5China
02 1Italy
03 1Sweden
04 1Switzerland
05 2U.S.A
06 2Blank
01 5Active
02 7Inactive
01 3Complete
02 9Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12679
Submission : 1997-10-02
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-01-15
Pay. Date : 2012-12-24
DMF Number : 6778
Submission : 1987-01-09
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 6789
Submission : 1987-01-23
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 6362
Submission : 1984-10-04
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-04-28
Pay. Date : 2013-12-24
DMF Number : 23216
Submission : 2009-10-21
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2019-01-22
Pay. Date : 2018-11-26
DMF Number : 29555
Submission : 2015-07-17
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23217
Submission : 2009-10-21
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5607
Submission : 1984-11-15
Status : Inactive
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 6803
Submission : 1987-02-05
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 6777
Submission : 1987-01-09
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
A Isosorbide Mononitrate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Isosorbide Mononitrate, including repackagers and relabelers. The FDA regulates Isosorbide Mononitrate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Isosorbide Mononitrate 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 Isosorbide Mononitrate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Isosorbide Mononitrate supplier is an individual or a company that provides Isosorbide Mononitrate active pharmaceutical ingredient (API) or Isosorbide Mononitrate finished formulations upon request. The Isosorbide Mononitrate suppliers may include Isosorbide Mononitrate API manufacturers, exporters, distributors and traders.
click here to find a list of Isosorbide Mononitrate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Isosorbide Mononitrate DMF (Drug Master File) is a document detailing the whole manufacturing process of Isosorbide Mononitrate active pharmaceutical ingredient (API) in detail. Different forms of Isosorbide Mononitrate DMFs exist exist since differing nations have different regulations, such as Isosorbide Mononitrate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Isosorbide Mononitrate DMF submitted to regulatory agencies in the US is known as a USDMF. Isosorbide Mononitrate USDMF includes data on Isosorbide Mononitrate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Isosorbide Mononitrate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Isosorbide Mononitrate suppliers with USDMF on PharmaCompass.
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