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API SUPPLIERS
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USDMF
Chongqing Sintaho Pharma: A trusted partner globally for chemosynthetic APIs.
GDUFA
DMF Review : Complete
Rev. Date : 2023-11-13
Pay. Date : 2023-09-22
DMF Number : 37559
Submission : 2023-01-31
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
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
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A Eribulin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Eribulin, including repackagers and relabelers. The FDA regulates Eribulin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Eribulin 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 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Eribulin supplier is an individual or a company that provides Eribulin active pharmaceutical ingredient (API) or Eribulin finished formulations upon request. The Eribulin suppliers may include Eribulin API manufacturers, exporters, distributors and traders.
click here to find a list of Eribulin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Eribulin DMF (Drug Master File) is a document detailing the whole manufacturing process of Eribulin active pharmaceutical ingredient (API) in detail. Different forms of Eribulin DMFs exist exist since differing nations have different regulations, such as Eribulin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Eribulin DMF submitted to regulatory agencies in the US is known as a USDMF. Eribulin USDMF includes data on Eribulin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Eribulin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Eribulin 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 Drug Master File in Japan (Eribulin JDMF) empowers Eribulin 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 JDMF during the approval evaluation for pharmaceutical products. At the time of Eribulin 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 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 Drug Master File in Korea (Eribulin KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Eribulin. The MFDS reviews the Eribulin KDMF as part of the drug registration process and uses the information provided in the Eribulin KDMF to evaluate the safety and efficacy of the drug.
After submitting a Eribulin 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 API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Eribulin suppliers with KDMF 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 as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Eribulin 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 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 and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Eribulin NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Eribulin suppliers with NDC on PharmaCompass.
Eribulin 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 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 GMP manufacturer or Eribulin GMP API supplier for your needs.
A Eribulin CoA (Certificate of Analysis) is a formal document that attests to Eribulin's compliance with Eribulin specifications and serves as a tool for batch-level quality control.
Eribulin CoA mostly includes findings from lab analyses of a specific batch. For each Eribulin 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 may be tested according to a variety of international standards, such as European Pharmacopoeia (Eribulin EP), Eribulin JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Eribulin USP).
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