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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.
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 Drug Master File in Japan (Isosorbide JDMF) empowers Isosorbide 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 JDMF during the approval evaluation for pharmaceutical products. At the time of Isosorbide 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 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 Drug Master File in Korea (Isosorbide KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Isosorbide. The MFDS reviews the Isosorbide KDMF as part of the drug registration process and uses the information provided in the Isosorbide KDMF to evaluate the safety and efficacy of the drug.
After submitting a Isosorbide 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 API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Isosorbide suppliers with KDMF on PharmaCompass.
A Isosorbide written confirmation (Isosorbide WC) is an official document issued by a regulatory agency to a Isosorbide manufacturer, verifying that the manufacturing facility of a Isosorbide active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Isosorbide APIs or Isosorbide finished pharmaceutical products to another nation, regulatory agencies frequently require a Isosorbide WC (written confirmation) as part of the regulatory process.
click here to find a list of Isosorbide suppliers with Written Confirmation (WC) on PharmaCompass.
Isosorbide 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 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 GMP manufacturer or Isosorbide GMP API supplier for your needs.
A Isosorbide CoA (Certificate of Analysis) is a formal document that attests to Isosorbide's compliance with Isosorbide specifications and serves as a tool for batch-level quality control.
Isosorbide CoA mostly includes findings from lab analyses of a specific batch. For each Isosorbide 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 may be tested according to a variety of international standards, such as European Pharmacopoeia (Isosorbide EP), Isosorbide JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Isosorbide USP).
