01 1DOTTIKON EXCLUSIVE SYNTHESIS AG
02 1Blank
01 1ISOSORBIDE CONCENTRATE
02 1ISOSORBIDE-5-NITRATE EXTENDED RELEASE PREMIXTURE 49.2%
01 1Switzerland
02 1Blank
01 2Inactive
01 2Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10823
Submission : 1994-03-18
Status : Inactive
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12564
Submission : 1997-06-25
Status : Inactive
Type : II
Portfolio PDF
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PharmaCompass offers a list of Isosorbide API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Isosorbide manufacturer or Isosorbide supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Isosorbide manufacturer or Isosorbide supplier.
PharmaCompass also assists you with knowing the Isosorbide API Price utilized in the formulation of products. Isosorbide API Price is not always fixed or binding as the Isosorbide Price is obtained through a variety of data sources. The Isosorbide Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Isosorbide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Isosorbide, including repackagers and relabelers. The FDA regulates Isosorbide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Isosorbide 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 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Isosorbide supplier is an individual or a company that provides Isosorbide active pharmaceutical ingredient (API) or Isosorbide finished formulations upon request. The Isosorbide suppliers may include Isosorbide API manufacturers, exporters, distributors and traders.
click here to find a list of Isosorbide suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Isosorbide DMF (Drug Master File) is a document detailing the whole manufacturing process of Isosorbide active pharmaceutical ingredient (API) in detail. Different forms of Isosorbide DMFs exist exist since differing nations have different regulations, such as Isosorbide USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Isosorbide DMF submitted to regulatory agencies in the US is known as a USDMF. Isosorbide USDMF includes data on Isosorbide's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Isosorbide USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Isosorbide suppliers with USDMF on PharmaCompass.
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