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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 USDMF

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.

Isosorbide Mononitrate JDMF

The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.

The Isosorbide Mononitrate Drug Master File in Japan (Isosorbide Mononitrate JDMF) empowers Isosorbide Mononitrate API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).

PMDA reviews the Isosorbide Mononitrate JDMF during the approval evaluation for pharmaceutical products. At the time of Isosorbide Mononitrate JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.

click here to find a list of Isosorbide Mononitrate suppliers with JDMF on PharmaCompass.

Isosorbide Mononitrate KDMF

In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

Pharmaceutical companies submit a Isosorbide Mononitrate Drug Master File in Korea (Isosorbide Mononitrate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Isosorbide Mononitrate. The MFDS reviews the Isosorbide Mononitrate KDMF as part of the drug registration process and uses the information provided in the Isosorbide Mononitrate KDMF to evaluate the safety and efficacy of the drug.

After submitting a Isosorbide Mononitrate KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Isosorbide Mononitrate API can apply through the Korea Drug Master File (KDMF).

click here to find a list of Isosorbide Mononitrate suppliers with KDMF 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 WC

A Isosorbide Mononitrate written confirmation (Isosorbide Mononitrate WC) is an official document issued by a regulatory agency to a Isosorbide Mononitrate manufacturer, verifying that the manufacturing facility of a Isosorbide Mononitrate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Isosorbide Mononitrate APIs or Isosorbide Mononitrate finished pharmaceutical products to another nation, regulatory agencies frequently require a Isosorbide Mononitrate WC (written confirmation) as part of the regulatory process.

click here to find a list of Isosorbide Mononitrate suppliers with Written Confirmation (WC) on PharmaCompass.

Isosorbide Mononitrate NDC

National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Isosorbide Mononitrate as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Isosorbide Mononitrate API and other APIs are published in this directory by the FDA.

Unfinished drugs

The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.

Pharmaceutical companies that manufacture Isosorbide Mononitrate as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.

Compounded drug products

The NDC directory also contains data on finished compounded human drug products that contain Isosorbide Mononitrate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Isosorbide Mononitrate NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of Isosorbide Mononitrate suppliers with NDC on PharmaCompass.

Isosorbide Mononitrate GMP

Isosorbide Mononitrate Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.

GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).

PharmaCompass offers a list of Isosorbide Mononitrate GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Isosorbide Mononitrate GMP manufacturer or Isosorbide Mononitrate GMP API supplier for your needs.

Isosorbide Mononitrate CoA

A Isosorbide Mononitrate CoA (Certificate of Analysis) is a formal document that attests to Isosorbide Mononitrate's compliance with Isosorbide Mononitrate specifications and serves as a tool for batch-level quality control.

Isosorbide Mononitrate CoA mostly includes findings from lab analyses of a specific batch. For each Isosorbide Mononitrate CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.

Isosorbide Mononitrate may be tested according to a variety of international standards, such as European Pharmacopoeia (Isosorbide Mononitrate EP), Isosorbide Mononitrate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Isosorbide Mononitrate USP).

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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