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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.
A Imdur manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Imdur, including repackagers and relabelers. The FDA regulates Imdur manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Imdur 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 Imdur manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Imdur supplier is an individual or a company that provides Imdur active pharmaceutical ingredient (API) or Imdur finished formulations upon request. The Imdur suppliers may include Imdur API manufacturers, exporters, distributors and traders.
click here to find a list of Imdur suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Imdur DMF (Drug Master File) is a document detailing the whole manufacturing process of Imdur active pharmaceutical ingredient (API) in detail. Different forms of Imdur DMFs exist exist since differing nations have different regulations, such as Imdur USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Imdur DMF submitted to regulatory agencies in the US is known as a USDMF. Imdur USDMF includes data on Imdur's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Imdur USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Imdur 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 Imdur Drug Master File in Japan (Imdur JDMF) empowers Imdur 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 Imdur JDMF during the approval evaluation for pharmaceutical products. At the time of Imdur 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 Imdur 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 Imdur Drug Master File in Korea (Imdur KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Imdur. The MFDS reviews the Imdur KDMF as part of the drug registration process and uses the information provided in the Imdur KDMF to evaluate the safety and efficacy of the drug.
After submitting a Imdur 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 Imdur API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Imdur suppliers with KDMF on PharmaCompass.
A Imdur CEP of the European Pharmacopoeia monograph is often referred to as a Imdur Certificate of Suitability (COS). The purpose of a Imdur CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Imdur EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Imdur to their clients by showing that a Imdur CEP has been issued for it. The manufacturer submits a Imdur CEP (COS) as part of the market authorization procedure, and it takes on the role of a Imdur CEP holder for the record. Additionally, the data presented in the Imdur CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Imdur DMF.
A Imdur CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Imdur 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 Imdur suppliers with CEP (COS) on PharmaCompass.
A Imdur written confirmation (Imdur WC) is an official document issued by a regulatory agency to a Imdur manufacturer, verifying that the manufacturing facility of a Imdur active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Imdur APIs or Imdur finished pharmaceutical products to another nation, regulatory agencies frequently require a Imdur WC (written confirmation) as part of the regulatory process.
click here to find a list of Imdur suppliers with Written Confirmation (WC) 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 Imdur as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Imdur 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 Imdur 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 Imdur and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Imdur NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Imdur suppliers with NDC on PharmaCompass.
Imdur 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 Imdur 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 Imdur GMP manufacturer or Imdur GMP API supplier for your needs.
A Imdur CoA (Certificate of Analysis) is a formal document that attests to Imdur's compliance with Imdur specifications and serves as a tool for batch-level quality control.
Imdur CoA mostly includes findings from lab analyses of a specific batch. For each Imdur 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.
Imdur may be tested according to a variety of international standards, such as European Pharmacopoeia (Imdur EP), Imdur JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Imdur USP).
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