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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.
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
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USDMF
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : Complete
Rev. Date : 2022-02-03
Pay. Date : 2021-12-17
DMF Number : 36433
Submission : 2021-11-30
Status :
Type : II
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35948
Submission : 2021-05-27
Status :
Type : II
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DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
About the Company : Founded in 1984, DRL is well-known for its generic APIs and its track record in drug product development. It is one of the earliest pharma API manufacturers with a diverse portfoli...
TransoPharm USA works in the Sourcing and Management of Active Pharmaceutical Ingredients.
About the Company : Transo-Pharm, a fully licensed and certified distributor, specializes in pharmaceutical components for the health and veterinary industries. It offers support to clients throughout...
Shanghai Minbiotech is the leading producer of biopharmaceuticals and a variety of high-end generic & innovative drugs.
About the Company : Headquartered in Fengxian District, Shanghai Minbiotech Co., Ltd. is a company specializing in the R&D and production of advanced pharmaceutical intermediates and biological API...
ChemExpress delivers end-to-end CRO & CDMO solutions for small molecules, biologics & novel modalities with ICH-grade quality.
About the Company : ChemExpress is a leading CRO and CDMO partner supporting pharmaceutical and biotech companies worldwide. We specialize in small molecules, biologics, and next-gen modalities includ...
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API/FDF Prices: Book a Demo to explore the features and consider upgrading later
API Imports and Exports
Drugs in Development
Lead Product(s) : Eribulin
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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Shanghai Minbiotech is the leading producer of biopharmaceuticals and a variety of high-end generic & innovative drugs.
Methyl 2-((2R,4aS,6S,7R,8S,8aS)-7,8-bis((tert-buty...
CAS Number : 157322-83-3
End Use API : Eribulin
About The Company : Headquartered in Fengxian District, Shanghai Minbiotech Co., Ltd. is a company specializing in the R&D and production of advanced pharmaceutical intermediate...
Shanghai Minbiotech is the leading producer of biopharmaceuticals and a variety of high-end generic & innovative drugs.
3,6-Anhydro-2,4,7-trideoxy-8,9-bis-O-[(1,1-dimethy...
CAS Number : 871348-24-2
End Use API : Eribulin
About The Company : Headquartered in Fengxian District, Shanghai Minbiotech Co., Ltd. is a company specializing in the R&D and production of advanced pharmaceutical intermediate...
Shanghai Minbiotech is the leading producer of biopharmaceuticals and a variety of high-end generic & innovative drugs.
CAS Number : 157322-47-9
End Use API : Eribulin
About The Company : Headquartered in Fengxian District, Shanghai Minbiotech Co., Ltd. is a company specializing in the R&D and production of advanced pharmaceutical intermediate...
Shanghai Minbiotech is the leading producer of biopharmaceuticals and a variety of high-end generic & innovative drugs.
(2-Furanpropanol, 5-[2-[(2S,4R,6R)-6-[[(2S,3S,4R,5...
CAS Number : 253128-10-8
End Use API : Eribulin
About The Company : Headquartered in Fengxian District, Shanghai Minbiotech Co., Ltd. is a company specializing in the R&D and production of advanced pharmaceutical intermediate...
ChemExpress delivers end-to-end CRO & CDMO solutions for small molecules, biologics & novel modalities with ICH-grade quality.
CAS Number : 157322-83-3
End Use API : Eribulin
About The Company : ChemExpress is a leading CRO and CDMO partner supporting pharmaceutical and biotech companies worldwide. We specialize in small molecules, biologics, and next-g...
ChemExpress delivers end-to-end CRO & CDMO solutions for small molecules, biologics & novel modalities with ICH-grade quality.
CAS Number : 157322-47-9
End Use API : Eribulin
About The Company : ChemExpress is a leading CRO and CDMO partner supporting pharmaceutical and biotech companies worldwide. We specialize in small molecules, biologics, and next-g...
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DATA COMPILATION #PharmaFlow
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US Medicaid Prescriptions
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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 Eribulin Mesylate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Eribulin Mesylate, including repackagers and relabelers. The FDA regulates Eribulin Mesylate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Eribulin Mesylate 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 Eribulin Mesylate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Eribulin Mesylate supplier is an individual or a company that provides Eribulin Mesylate active pharmaceutical ingredient (API) or Eribulin Mesylate finished formulations upon request. The Eribulin Mesylate suppliers may include Eribulin Mesylate API manufacturers, exporters, distributors and traders.
click here to find a list of Eribulin Mesylate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Eribulin Mesylate DMF (Drug Master File) is a document detailing the whole manufacturing process of Eribulin Mesylate active pharmaceutical ingredient (API) in detail. Different forms of Eribulin Mesylate DMFs exist exist since differing nations have different regulations, such as Eribulin Mesylate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Eribulin Mesylate DMF submitted to regulatory agencies in the US is known as a USDMF. Eribulin Mesylate USDMF includes data on Eribulin Mesylate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Eribulin Mesylate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Eribulin Mesylate 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 Eribulin Mesylate Drug Master File in Japan (Eribulin Mesylate JDMF) empowers Eribulin Mesylate 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 Eribulin Mesylate JDMF during the approval evaluation for pharmaceutical products. At the time of Eribulin Mesylate 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 Eribulin Mesylate 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 Eribulin Mesylate Drug Master File in Korea (Eribulin Mesylate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Eribulin Mesylate. The MFDS reviews the Eribulin Mesylate KDMF as part of the drug registration process and uses the information provided in the Eribulin Mesylate KDMF to evaluate the safety and efficacy of the drug.
After submitting a Eribulin Mesylate 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 Eribulin Mesylate API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Eribulin Mesylate suppliers with KDMF on PharmaCompass.
A Eribulin Mesylate written confirmation (Eribulin Mesylate WC) is an official document issued by a regulatory agency to a Eribulin Mesylate manufacturer, verifying that the manufacturing facility of a Eribulin Mesylate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Eribulin Mesylate APIs or Eribulin Mesylate finished pharmaceutical products to another nation, regulatory agencies frequently require a Eribulin Mesylate WC (written confirmation) as part of the regulatory process.
click here to find a list of Eribulin Mesylate 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 Eribulin Mesylate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Eribulin Mesylate 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 Eribulin Mesylate 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 Eribulin Mesylate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Eribulin Mesylate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Eribulin Mesylate suppliers with NDC on PharmaCompass.
Eribulin Mesylate 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 Eribulin Mesylate 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 Eribulin Mesylate GMP manufacturer or Eribulin Mesylate GMP API supplier for your needs.
A Eribulin Mesylate CoA (Certificate of Analysis) is a formal document that attests to Eribulin Mesylate's compliance with Eribulin Mesylate specifications and serves as a tool for batch-level quality control.
Eribulin Mesylate CoA mostly includes findings from lab analyses of a specific batch. For each Eribulin Mesylate 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.
Eribulin Mesylate may be tested according to a variety of international standards, such as European Pharmacopoeia (Eribulin Mesylate EP), Eribulin Mesylate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Eribulin Mesylate USP).
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