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API SUPPLIERS
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
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TransoPharm USA works in the Sourcing and Management of Active Pharmaceutical Ingredients.
Shanghai Minbiotech is the leading producer of biopharmaceuticals and a variety of high-end generic & innovative drugs.
ChemExpress delivers end-to-end CRO & CDMO solutions for small molecules, biologics & novel modalities with ICH-grade quality.
ASMF
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
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USDMF
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API Imports and Exports
Drugs in Development
Lead Product(s) : Eribulin,Inapplicable
Therapeutic Area : Oncology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
EVER Pharma gained EU-Approval for Advanced Cancer Treatment
Details : Eribulin EVER Pharma is a microtubule inhibitor which is indicated for the treatment of locally advanced or metastatic breast cancer and unresectable liposarcoma.
Product Name : Eribulin EVER Pharma
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
August 16, 2024
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ABOUT THIS PAGE
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PharmaCompass offers a list of Eribulin 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 Eribulin manufacturer or Eribulin supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Eribulin manufacturer or Eribulin supplier.
PharmaCompass also assists you with knowing the Eribulin API Price utilized in the formulation of products. Eribulin API Price is not always fixed or binding as the Eribulin Price is obtained through a variety of data sources. The Eribulin Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Halaven manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Halaven, including repackagers and relabelers. The FDA regulates Halaven manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Halaven 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 Halaven manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Halaven supplier is an individual or a company that provides Halaven active pharmaceutical ingredient (API) or Halaven finished formulations upon request. The Halaven suppliers may include Halaven API manufacturers, exporters, distributors and traders.
click here to find a list of Halaven suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Halaven DMF (Drug Master File) is a document detailing the whole manufacturing process of Halaven active pharmaceutical ingredient (API) in detail. Different forms of Halaven DMFs exist exist since differing nations have different regulations, such as Halaven USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Halaven DMF submitted to regulatory agencies in the US is known as a USDMF. Halaven USDMF includes data on Halaven's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Halaven USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Halaven 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 Halaven Drug Master File in Japan (Halaven JDMF) empowers Halaven 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 Halaven JDMF during the approval evaluation for pharmaceutical products. At the time of Halaven 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 Halaven 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 Halaven Drug Master File in Korea (Halaven KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Halaven. The MFDS reviews the Halaven KDMF as part of the drug registration process and uses the information provided in the Halaven KDMF to evaluate the safety and efficacy of the drug.
After submitting a Halaven 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 Halaven API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Halaven suppliers with KDMF on PharmaCompass.
A Halaven written confirmation (Halaven WC) is an official document issued by a regulatory agency to a Halaven manufacturer, verifying that the manufacturing facility of a Halaven active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Halaven APIs or Halaven finished pharmaceutical products to another nation, regulatory agencies frequently require a Halaven WC (written confirmation) as part of the regulatory process.
click here to find a list of Halaven suppliers with Written Confirmation (WC) on PharmaCompass.
National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Halaven as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Halaven API and other APIs are published in this directory by the FDA.
The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.
Pharmaceutical companies that manufacture Halaven as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.
The NDC directory also contains data on finished compounded human drug products that contain Halaven and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Halaven NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Halaven suppliers with NDC on PharmaCompass.
Halaven 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 Halaven 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 Halaven GMP manufacturer or Halaven GMP API supplier for your needs.
A Halaven CoA (Certificate of Analysis) is a formal document that attests to Halaven's compliance with Halaven specifications and serves as a tool for batch-level quality control.
Halaven CoA mostly includes findings from lab analyses of a specific batch. For each Halaven 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.
Halaven may be tested according to a variety of international standards, such as European Pharmacopoeia (Halaven EP), Halaven JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Halaven USP).
