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API SUPPLIERS
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USDMF
Axplora is your partner of choice for complex APIs.
GDUFA
DMF Review : Complete
Rev. Date : 2023-06-07
Pay. Date : 2023-06-05
DMF Number : 27182
Submission : 2013-05-23
Status :
Type : II
Chunghwa provides cost-effective APIs & advanced intermediates with complete DMF or COS, ensuring quality & reliable production.
GDUFA
DMF Review : Complete
Rev. Date : 2013-04-01
Pay. Date : 2012-11-20
DMF Number : 26271
Submission : 2012-08-01
Status :
Type : II
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]JDMF
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Listed Suppliers
Axplora is your partner of choice for complex APIs.
About the Company : Axplora, created from the merger of Farmabios, Novasep & PharmaZell, is a leading API manufacturing partner to the world’s leading pharma & biotech companies, delivering top-qual...
DKSH is your trusted partner for companies looking to grow their business in Asia & beyond.
About the Company : DKSH, founded with the goal of improving people's lives, assists businesses with market expansion and business growth in both existing and emerging markets. It has been fostering g...
Chunghwa provides cost-effective APIs & advanced intermediates with complete DMF or COS, ensuring quality & reliable production.
About the Company : Chunghwa Chemical Synthesis & Biotech Co. Ltd. (CCSB) offers global customers cost-effective APIs with speed, supported by our well-trained staff. As the first company in Southeast...
Chunghwa provides cost-effective APIs & advanced intermediates with complete DMF or COS, ensuring quality & reliable production.
About the Company : Chunghwa Chemical Synthesis & Biotech Co. Ltd. (CCSB) offers global customers cost-effective APIs with speed, supported by our well-trained staff. As the first company in Southeast...
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]API Reference Price
API/FDF Prices: Book a Demo to explore the features and consider upgrading later
API Imports and Exports
Drugs in Development
Lead Product(s) : Icosapent Ethyl,Inapplicable
Therapeutic Area : Cardiology/Vascular Diseases
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Dr Reddy's Laboratories launches Icosapent Ethyl Capsules in US
Details : Dr Reddy's Laboratories announced the launch of Icosapent Ethyl Capsules, used to reduce triglyceride (TG) levels in adult patients, in the US market. Dr Reddy's Icosapent Ethyl is available in 1 gram capsules in bottle count size of 120's count.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
June 22, 2021
Lead Product(s) : Icosapent Ethyl,Inapplicable
Therapeutic Area : Cardiology/Vascular Diseases
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Amneal Pharmaceuticals
Deal Size : Inapplicable
Deal Type : Inapplicable
Strides Launches Icosapent Ethyl Acid Soft Gel Capsules in Partnership with Amneal
Details : Vascepa-Generic (icosapent ethyl) is an ethyl ester of eicosapentaenoic acid (EPA) which is indicated to reduce the risk of myocardial infarction, stroke, coronary revascularization, and unstable angina.
Product Name : Vascepa-Generic
Product Type : Miscellaneous
Upfront Cash : Inapplicable
December 02, 2023
Lead Product(s) : Icosapent Ethyl,Inapplicable
Therapeutic Area : Cardiology/Vascular Diseases
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Amneal Pharmaceuticals
Deal Size : Undisclosed
Deal Type : Licensing Agreement
Amneal Expands Portfolio with Addition of Icosapent Ethyl Acid Soft Gel Capsules
Details : Under the agreement, Amneal in-licensed Icosapent ethyl acid soft gel capsules, a product referencing Vascepa and an ethyl ester of eicosapentaenoic acid that is indicated as an adjunct to diet to reduce triglyceride levels in adult patients with severe ...
Product Name : Vascepa-Generic
Product Type : Miscellaneous
Upfront Cash : Undisclosed
December 01, 2023
Lead Product(s) : Icosapent Ethyl,Inapplicable
Therapeutic Area : Cardiology/Vascular Diseases
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Strides Receives USFDA Approval for Icosapent Ethyl Capsules
Details : Icosapent ethyl capsules is an ethyl ester of eicosapentaenoic acid (EPA), which is indicated for the treatment of to reduce the risk of myocardial infarction, stroke, coronary revascularization, and unstable angina in adult patients with elevated trigly...
Product Name : Vascepa-Generic
Product Type : Miscellaneous
Upfront Cash : Inapplicable
October 03, 2023
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EUROAPI
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Thickeners and Stabilizers
Fillers, Diluents & Binders
Film Formers & Plasticizers
Solubilizers
Taste Masking
Topical
Coating Systems & Additives
Empty Capsules
Emulsifying Agents
Chewable & Orodispersible Aids
Surfactant & Foaming Agents
Coloring Agents
Co-Processed Excipients
Disintegrants & Superdisintegrants
Direct Compression
Lubricants & Glidants
API Stability Enhancers
Rheology Modifiers
Controlled & Modified Release
Soft Gelatin
Digital Content
NEWS #PharmaBuzz
Global Sales Information
US Medicaid Prescriptions
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
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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 Ethyl manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Icosapent Ethyl, including repackagers and relabelers. The FDA regulates Icosapent Ethyl manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Icosapent Ethyl 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 Ethyl manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Icosapent Ethyl supplier is an individual or a company that provides Icosapent Ethyl active pharmaceutical ingredient (API) or Icosapent Ethyl finished formulations upon request. The Icosapent Ethyl suppliers may include Icosapent Ethyl API manufacturers, exporters, distributors and traders.
click here to find a list of Icosapent Ethyl suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Icosapent Ethyl DMF (Drug Master File) is a document detailing the whole manufacturing process of Icosapent Ethyl active pharmaceutical ingredient (API) in detail. Different forms of Icosapent Ethyl DMFs exist exist since differing nations have different regulations, such as Icosapent Ethyl USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Icosapent Ethyl DMF submitted to regulatory agencies in the US is known as a USDMF. Icosapent Ethyl USDMF includes data on Icosapent Ethyl's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Icosapent Ethyl USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Icosapent Ethyl 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 Ethyl Drug Master File in Japan (Icosapent Ethyl JDMF) empowers Icosapent Ethyl 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 Ethyl JDMF during the approval evaluation for pharmaceutical products. At the time of Icosapent Ethyl 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 Ethyl 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 Ethyl Drug Master File in Korea (Icosapent Ethyl KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Icosapent Ethyl. The MFDS reviews the Icosapent Ethyl KDMF as part of the drug registration process and uses the information provided in the Icosapent Ethyl KDMF to evaluate the safety and efficacy of the drug.
After submitting a Icosapent Ethyl 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 Ethyl API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Icosapent Ethyl suppliers with KDMF on PharmaCompass.
Icosapent Ethyl 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 Ethyl 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 Ethyl GMP manufacturer or Icosapent Ethyl GMP API supplier for your needs.
A Icosapent Ethyl CoA (Certificate of Analysis) is a formal document that attests to Icosapent Ethyl's compliance with Icosapent Ethyl specifications and serves as a tool for batch-level quality control.
Icosapent Ethyl CoA mostly includes findings from lab analyses of a specific batch. For each Icosapent Ethyl 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 Ethyl may be tested according to a variety of international standards, such as European Pharmacopoeia (Icosapent Ethyl EP), Icosapent Ethyl JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Icosapent Ethyl USP).
