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PharmaCompass offers a list of Isosorbide Dinitrate 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 Dinitrate manufacturer or Isosorbide Dinitrate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Isosorbide Dinitrate manufacturer or Isosorbide Dinitrate supplier.
PharmaCompass also assists you with knowing the Isosorbide Dinitrate API Price utilized in the formulation of products. Isosorbide Dinitrate API Price is not always fixed or binding as the Isosorbide Dinitrate Price is obtained through a variety of data sources. The Isosorbide Dinitrate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Isosorbide Dinitrate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Isosorbide Dinitrate, including repackagers and relabelers. The FDA regulates Isosorbide Dinitrate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Isosorbide Dinitrate 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 Dinitrate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Isosorbide Dinitrate supplier is an individual or a company that provides Isosorbide Dinitrate active pharmaceutical ingredient (API) or Isosorbide Dinitrate finished formulations upon request. The Isosorbide Dinitrate suppliers may include Isosorbide Dinitrate API manufacturers, exporters, distributors and traders.
click here to find a list of Isosorbide Dinitrate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Isosorbide Dinitrate DMF (Drug Master File) is a document detailing the whole manufacturing process of Isosorbide Dinitrate active pharmaceutical ingredient (API) in detail. Different forms of Isosorbide Dinitrate DMFs exist exist since differing nations have different regulations, such as Isosorbide Dinitrate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Isosorbide Dinitrate DMF submitted to regulatory agencies in the US is known as a USDMF. Isosorbide Dinitrate USDMF includes data on Isosorbide Dinitrate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Isosorbide Dinitrate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Isosorbide Dinitrate suppliers with USDMF on PharmaCompass.
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 Dinitrate Drug Master File in Japan (Isosorbide Dinitrate JDMF) empowers Isosorbide Dinitrate 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 Dinitrate JDMF during the approval evaluation for pharmaceutical products. At the time of Isosorbide Dinitrate 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 Dinitrate suppliers with JDMF on PharmaCompass.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Isosorbide Dinitrate Drug Master File in Korea (Isosorbide Dinitrate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Isosorbide Dinitrate. The MFDS reviews the Isosorbide Dinitrate KDMF as part of the drug registration process and uses the information provided in the Isosorbide Dinitrate KDMF to evaluate the safety and efficacy of the drug.
After submitting a Isosorbide Dinitrate 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 Dinitrate API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Isosorbide Dinitrate suppliers with KDMF on PharmaCompass.
A Isosorbide Dinitrate CEP of the European Pharmacopoeia monograph is often referred to as a Isosorbide Dinitrate Certificate of Suitability (COS). The purpose of a Isosorbide Dinitrate CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Isosorbide Dinitrate EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Isosorbide Dinitrate to their clients by showing that a Isosorbide Dinitrate CEP has been issued for it. The manufacturer submits a Isosorbide Dinitrate CEP (COS) as part of the market authorization procedure, and it takes on the role of a Isosorbide Dinitrate CEP holder for the record. Additionally, the data presented in the Isosorbide Dinitrate CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Isosorbide Dinitrate DMF.
A Isosorbide Dinitrate CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Isosorbide Dinitrate 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 Dinitrate suppliers with CEP (COS) on PharmaCompass.
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 Dinitrate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Isosorbide Dinitrate API and other APIs are published in this directory by the FDA.
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 Dinitrate 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.
The NDC directory also contains data on finished compounded human drug products that contain Isosorbide Dinitrate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Isosorbide Dinitrate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Isosorbide Dinitrate suppliers with NDC on PharmaCompass.
Isosorbide Dinitrate 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 Dinitrate 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 Dinitrate GMP manufacturer or Isosorbide Dinitrate GMP API supplier for your needs.
A Isosorbide Dinitrate CoA (Certificate of Analysis) is a formal document that attests to Isosorbide Dinitrate's compliance with Isosorbide Dinitrate specifications and serves as a tool for batch-level quality control.
Isosorbide Dinitrate CoA mostly includes findings from lab analyses of a specific batch. For each Isosorbide Dinitrate 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 Dinitrate may be tested according to a variety of international standards, such as European Pharmacopoeia (Isosorbide Dinitrate EP), Isosorbide Dinitrate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Isosorbide Dinitrate USP).
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