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PharmaCompass offers a list of Icosapent Ethyl 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 Icosapent Ethyl manufacturer or Icosapent Ethyl supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Icosapent Ethyl manufacturer or Icosapent Ethyl supplier.
PharmaCompass also assists you with knowing the Icosapent Ethyl API Price utilized in the formulation of products. Icosapent Ethyl API Price is not always fixed or binding as the Icosapent Ethyl Price is obtained through a variety of data sources. The Icosapent Ethyl Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Icosapent manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Icosapent, including repackagers and relabelers. The FDA regulates Icosapent manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Icosapent 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 Icosapent manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Icosapent supplier is an individual or a company that provides Icosapent active pharmaceutical ingredient (API) or Icosapent finished formulations upon request. The Icosapent suppliers may include Icosapent API manufacturers, exporters, distributors and traders.
click here to find a list of Icosapent suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Icosapent DMF (Drug Master File) is a document detailing the whole manufacturing process of Icosapent active pharmaceutical ingredient (API) in detail. Different forms of Icosapent DMFs exist exist since differing nations have different regulations, such as Icosapent USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Icosapent DMF submitted to regulatory agencies in the US is known as a USDMF. Icosapent USDMF includes data on Icosapent's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Icosapent USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Icosapent 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 Icosapent Drug Master File in Japan (Icosapent JDMF) empowers Icosapent 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 Icosapent JDMF during the approval evaluation for pharmaceutical products. At the time of Icosapent 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 Icosapent 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 Icosapent Drug Master File in Korea (Icosapent KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Icosapent. The MFDS reviews the Icosapent KDMF as part of the drug registration process and uses the information provided in the Icosapent KDMF to evaluate the safety and efficacy of the drug.
After submitting a Icosapent 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 Icosapent API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Icosapent suppliers with KDMF on PharmaCompass.
Icosapent 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 Icosapent 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 Icosapent GMP manufacturer or Icosapent GMP API supplier for your needs.
A Icosapent CoA (Certificate of Analysis) is a formal document that attests to Icosapent's compliance with Icosapent specifications and serves as a tool for batch-level quality control.
Icosapent CoA mostly includes findings from lab analyses of a specific batch. For each Icosapent 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.
Icosapent may be tested according to a variety of international standards, such as European Pharmacopoeia (Icosapent EP), Icosapent JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Icosapent USP).
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