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PharmaCompass offers a list of Omega-3-Acid Ethyl Esters 90 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 Omega-3-Acid Ethyl Esters 90 manufacturer or Omega-3-Acid Ethyl Esters 90 supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Omega-3-Acid Ethyl Esters 90 manufacturer or Omega-3-Acid Ethyl Esters 90 supplier.
PharmaCompass also assists you with knowing the Omega-3-Acid Ethyl Esters 90 API Price utilized in the formulation of products. Omega-3-Acid Ethyl Esters 90 API Price is not always fixed or binding as the Omega-3-Acid Ethyl Esters 90 Price is obtained through a variety of data sources. The Omega-3-Acid Ethyl Esters 90 Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Lovaza manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Lovaza, including repackagers and relabelers. The FDA regulates Lovaza manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Lovaza 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 Lovaza manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Lovaza supplier is an individual or a company that provides Lovaza active pharmaceutical ingredient (API) or Lovaza finished formulations upon request. The Lovaza suppliers may include Lovaza API manufacturers, exporters, distributors and traders.
click here to find a list of Lovaza suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Lovaza DMF (Drug Master File) is a document detailing the whole manufacturing process of Lovaza active pharmaceutical ingredient (API) in detail. Different forms of Lovaza DMFs exist exist since differing nations have different regulations, such as Lovaza USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Lovaza DMF submitted to regulatory agencies in the US is known as a USDMF. Lovaza USDMF includes data on Lovaza's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Lovaza USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Lovaza 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 Lovaza Drug Master File in Japan (Lovaza JDMF) empowers Lovaza 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 Lovaza JDMF during the approval evaluation for pharmaceutical products. At the time of Lovaza 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 Lovaza 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 Lovaza Drug Master File in Korea (Lovaza KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Lovaza. The MFDS reviews the Lovaza KDMF as part of the drug registration process and uses the information provided in the Lovaza KDMF to evaluate the safety and efficacy of the drug.
After submitting a Lovaza 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 Lovaza API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Lovaza suppliers with KDMF on PharmaCompass.
A Lovaza CEP of the European Pharmacopoeia monograph is often referred to as a Lovaza Certificate of Suitability (COS). The purpose of a Lovaza CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Lovaza EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Lovaza to their clients by showing that a Lovaza CEP has been issued for it. The manufacturer submits a Lovaza CEP (COS) as part of the market authorization procedure, and it takes on the role of a Lovaza CEP holder for the record. Additionally, the data presented in the Lovaza CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Lovaza DMF.
A Lovaza CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Lovaza 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 Lovaza suppliers with CEP (COS) on PharmaCompass.
Lovaza 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 Lovaza 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 Lovaza GMP manufacturer or Lovaza GMP API supplier for your needs.
A Lovaza CoA (Certificate of Analysis) is a formal document that attests to Lovaza's compliance with Lovaza specifications and serves as a tool for batch-level quality control.
Lovaza CoA mostly includes findings from lab analyses of a specific batch. For each Lovaza 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.
Lovaza may be tested according to a variety of international standards, such as European Pharmacopoeia (Lovaza EP), Lovaza JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Lovaza USP).