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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
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]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
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
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
EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.
Dosage Form : Tablet
Grade : Oral
EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.
Dosage Form : Cream / Lotion / Ointment
Grade : Topical, Parenteral
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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, 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.
A Eicosapentaenoic Acid manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Eicosapentaenoic Acid, including repackagers and relabelers. The FDA regulates Eicosapentaenoic Acid manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Eicosapentaenoic Acid 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 Eicosapentaenoic Acid manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Eicosapentaenoic Acid supplier is an individual or a company that provides Eicosapentaenoic Acid active pharmaceutical ingredient (API) or Eicosapentaenoic Acid finished formulations upon request. The Eicosapentaenoic Acid suppliers may include Eicosapentaenoic Acid API manufacturers, exporters, distributors and traders.
click here to find a list of Eicosapentaenoic Acid suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Eicosapentaenoic Acid DMF (Drug Master File) is a document detailing the whole manufacturing process of Eicosapentaenoic Acid active pharmaceutical ingredient (API) in detail. Different forms of Eicosapentaenoic Acid DMFs exist exist since differing nations have different regulations, such as Eicosapentaenoic Acid USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Eicosapentaenoic Acid DMF submitted to regulatory agencies in the US is known as a USDMF. Eicosapentaenoic Acid USDMF includes data on Eicosapentaenoic Acid's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Eicosapentaenoic Acid USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Eicosapentaenoic Acid 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 Eicosapentaenoic Acid Drug Master File in Japan (Eicosapentaenoic Acid JDMF) empowers Eicosapentaenoic Acid 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 Eicosapentaenoic Acid JDMF during the approval evaluation for pharmaceutical products. At the time of Eicosapentaenoic Acid 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 Eicosapentaenoic Acid 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 Eicosapentaenoic Acid Drug Master File in Korea (Eicosapentaenoic Acid KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Eicosapentaenoic Acid. The MFDS reviews the Eicosapentaenoic Acid KDMF as part of the drug registration process and uses the information provided in the Eicosapentaenoic Acid KDMF to evaluate the safety and efficacy of the drug.
After submitting a Eicosapentaenoic Acid 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 Eicosapentaenoic Acid API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Eicosapentaenoic Acid suppliers with KDMF on PharmaCompass.
Eicosapentaenoic Acid 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 Eicosapentaenoic Acid GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Eicosapentaenoic Acid GMP manufacturer or Eicosapentaenoic Acid GMP API supplier for your needs.
A Eicosapentaenoic Acid CoA (Certificate of Analysis) is a formal document that attests to Eicosapentaenoic Acid's compliance with Eicosapentaenoic Acid specifications and serves as a tool for batch-level quality control.
Eicosapentaenoic Acid CoA mostly includes findings from lab analyses of a specific batch. For each Eicosapentaenoic Acid 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.
Eicosapentaenoic Acid may be tested according to a variety of international standards, such as European Pharmacopoeia (Eicosapentaenoic Acid EP), Eicosapentaenoic Acid JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Eicosapentaenoic Acid USP).
