01 1DOTTIKON EXCLUSIVE SYNTHESIS AG
02 1Dipharma
03 1Industriale Chimica
04 1Kremers Urban Pharmaceuticals
05 1Lunan Pharmaceutical
06 1Lusochimica
07 1Mallinckrodt Pharmaceuticals
08 2Nitto Denko Avecia
09 1Stuart Therapeutics
10 5Blank
01 1DILUTED ISOSORBIDE DINITRATE
02 1DILUTED ISOSORBIDE DINITRATE USP
03 1ISORBIDE DINITRATE C.R. CAPS 80MG
04 3ISOSORBIDE DINITRATE
05 1ISOSORBIDE DINITRATE (ISDN)
06 1ISOSORBIDE DINITRATE DILUTED
07 1ISOSORBIDE DINITRATE INJECTION (50ML AND 100ML)
08 1ISOSORBIDE DINITRATE TIMED RELEASE PELLETS
09 1ISOSORBIDE DINITRATE TRANSDERMAL SUSPENSION
10 1ISOSORBIDE DINITRATE, DILUTED
11 1SDM 50 (STABILIZED 50/50 ISOSORBIDE DINITRATE-LACTOSE MIXTURE)
12 1SDM-25 (25/75 ISOSORBIDE DINITRATE-MANNITOL MIXTURE)
13 1SDM-40 (25% ISOSORBIDE DINITRATE IN LACTOSE)
01 1China
02 1Ireland
03 3Italy
04 1Switzerland
05 4U.S.A
06 5Blank
01 4Active
02 11Inactive
01 2Complete
02 13Blank
GDUFA
DMF Review : Complete
Rev. Date : 2016-06-15
Pay. Date : 2016-02-25
DMF Number : 3725
Submission : 1980-02-07
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 2663
Submission : 1976-05-07
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9228
Submission : 1991-07-11
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2024-03-12
Pay. Date : 2024-01-31
DMF Number : 36099
Submission : 2021-12-05
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 2713
Submission : 1976-07-22
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 345
Submission : 1959-09-10
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4172
Submission : 1981-05-21
Status : Inactive
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 1791
Submission : 1971-09-13
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 : 1021
Submission : 1967-01-12
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 : 2238
Submission : 1974-03-01
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
A ISD manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of ISD, including repackagers and relabelers. The FDA regulates ISD manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. ISD 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 ISD manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A ISD supplier is an individual or a company that provides ISD active pharmaceutical ingredient (API) or ISD finished formulations upon request. The ISD suppliers may include ISD API manufacturers, exporters, distributors and traders.
click here to find a list of ISD suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A ISD DMF (Drug Master File) is a document detailing the whole manufacturing process of ISD active pharmaceutical ingredient (API) in detail. Different forms of ISD DMFs exist exist since differing nations have different regulations, such as ISD USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A ISD DMF submitted to regulatory agencies in the US is known as a USDMF. ISD USDMF includes data on ISD's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The ISD USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of ISD suppliers with USDMF on PharmaCompass.
We have 9 companies offering ISD
Get in contact with the supplier of your choice:
LOOKING FOR A SUPPLIER?
