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List of Certificates of Suitability (CEPs) for Isosorbide Mononitrate Active Pharmaceutical Ingredient (API) issued by the EDQM. Original Data: EDQM Database

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01 CURIA INDIA PRIVATE LIMITED Hyderabad IN (1)

02 Calao s.r.l. Milano IT (1)

03 DIPHARMA FRANCIS S.R.L. Baranzate IT (3)

04 EIRCHEM PHARMA SERVICES LIMITED Shannon IE (1)

05 J P LABORATORIES PRIVATE LIMITED Daund IN (1)

06 SHANDONG KEYUAN PHARMACEUTICAL CO., LTD. Jinan CN (1)

07 SHANDONG NEW TIME PHARMACEUTICAL CO., LTD. Linyi CN (1)

08 Whyte Chemicals Finchley, London GB (1)

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01 Isosorbide mononitrate, diluted (2)

02 Isosorbide mononitrate, diluted, 70% and 80% (1)

03 Isosorbide mononitrate, diluted, 70% in Lactose (1)

04 Isosorbide mononitrate, diluted, 70%, 60%, 50%, 40% in lactose monohydrate (1)

05 Isosorbide mononitrate, diluted, 80% in Lactose (1)

06 Isosorbide mononitrate, diluted, 80% in lactose (1)

07 Isosorbide mononitrate, diluted, 80%, 40%, 25% and 20% in lactose (1)

08 Isosorbide mononitrate, diluted, 90% in lactose (1)

09 Isosorbide mononitrate, diluted, To 90%, 80%, 70%, 60%, 50%, 40%, 30%, 25% and 20% with lactose (1)

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01 China (2)

02 India (1)

03 Ireland (1)

04 Italy (3)

05 U.S.A (2)

06 United Kingdom (1)

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01 Valid (7)

02 Withdrawn by EDQM Failure to CEP procedure (2)

03 Withdrawn by Holder (1)

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R0-CEP 2001-329 - Rev 00
Withdrawn by EDQM F...
Chemical
2002-11-07
2004-01-06
1118
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R1-CEP 2006-299 - Rev 04
Valid
Chemical
2022-08-30
1118
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PHARMACOMPASS
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R1-CEP 2007-277 - Rev 02
Valid
Chemical
2021-12-01
1118
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PHARMACOMPASS
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R1-CEP 2007-271 - Rev 02
Valid
Chemical
2021-12-01
1118
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PHARMACOMPASS
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R1-CEP 2007-261 - Rev 02
Valid
Chemical
2021-12-01
1118
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PHARMACOMPASS
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R1-CEP 1998-134 - Rev 06
Valid
Chemical
2019-11-26
1118
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R1-CEP 2002-104 - Rev 02
Withdrawn by EDQM F...
Chemical
2013-03-19
2016-04-26
1118
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R0-CEP 2020-153 - Rev 00
Valid
Chemical
2022-05-11
1118
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PHARMACOMPASS
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R1-CEP 2008-112 - Rev 00
Valid
Chemical
2014-10-10
1118
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R0-CEP 1999-107 - Rev 00
Withdrawn by Holder
Chemical
2001-03-06
2002-12-02
1118
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Looking for 16051-77-7 / Isosorbide Mononitrate API manufacturers, exporters & distributors?

Isosorbide Mononitrate manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Isosorbide Mononitrate 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 Mononitrate manufacturer or Isosorbide Mononitrate supplier for your needs.

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Isosorbide Mononitrate manufacturer or Isosorbide Mononitrate supplier.

PharmaCompass also assists you with knowing the Isosorbide Mononitrate API Price utilized in the formulation of products. Isosorbide Mononitrate API Price is not always fixed or binding as the Isosorbide Mononitrate Price is obtained through a variety of data sources. The Isosorbide Mononitrate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

Isosorbide Mononitrate

Synonyms

Isosorbide 5-mononitrate, 16051-77-7, Imdur, Corangin, Monosorbitrate, Monoket

Cas Number

16051-77-7

Unique Ingredient Identifier (UNII)

LX1OH63030

About Isosorbide Mononitrate

Isosorbide Mononitrate is the mononitrate salt form of isosorbide, an organic nitrate with vasodilator activity. Isosorbide mononitrate relaxes vascular smooth muscle by formation of the free radical nitric oxide (NO), which is identical to the endothelium-derived relaxing factor (EDRF). NO activates guanylyl cyclase, thereby increasing the synthesis of cGMP within smooth muscle, resulting in dephosphorylation of light chain myosin and relaxation of peripheral arteries and veins. In addition, isosorbide mononitrate relaxes coronary arteries, thereby increasing the blood circulation through the ischemic area. (NCI05)

Isosorbide Mononitrate Manufacturers

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.

Isosorbide Mononitrate Suppliers

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.

Isosorbide Mononitrate CEP

A Isosorbide Mononitrate CEP of the European Pharmacopoeia monograph is often referred to as a Isosorbide Mononitrate Certificate of Suitability (COS). The purpose of a Isosorbide Mononitrate CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Isosorbide Mononitrate EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Isosorbide Mononitrate to their clients by showing that a Isosorbide Mononitrate CEP has been issued for it. The manufacturer submits a Isosorbide Mononitrate CEP (COS) as part of the market authorization procedure, and it takes on the role of a Isosorbide Mononitrate CEP holder for the record. Additionally, the data presented in the Isosorbide Mononitrate CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Isosorbide Mononitrate DMF.

A Isosorbide Mononitrate CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Isosorbide Mononitrate CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.

click here to find a list of Isosorbide Mononitrate suppliers with CEP (COS) on PharmaCompass.

Isosorbide Mononitrate Manufacturers | Traders | Suppliers

Isosorbide Mononitrate Manufacturers, Traders, Suppliers 1
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We have 8 companies offering Isosorbide Mononitrate

Get in contact with the supplier of your choice:

  1. Calao s.r.l. IT 20157 Milano
  2. Curia
  3. Dipharma
  4. EIRCHEM Pharma Services
  5. JP Laboratories
  6. Lunan Pharmaceutical
  7. Shandong Keyuan Pharmaceutical Co., Ltd.
  8. WHYTE CHEMICALS
Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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