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KDMF
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API SUPPLIERS
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USDMF
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
GDUFA
DMF Review : Complete
Rev. Date : 2024-02-27
Pay. Date : 2024-01-22
DMF Number : 34751
Submission : 2020-06-16
Status :
Type : II
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : Complete
Rev. Date : 2020-11-01
Pay. Date : 2020-09-21
DMF Number : 34449
Submission : 2019-12-31
Status :
Type : II
Medichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.
GDUFA
DMF Review : Complete
Rev. Date : 2020-12-04
Pay. Date : 2020-10-15
DMF Number : 35211
Submission : 2020-10-26
Status :
Type : II
Neuland Laboratories- A dedicated 100% API provider.
GDUFA
DMF Review : Complete
Rev. Date : 2020-12-16
Pay. Date : 2020-10-23
DMF Number : 35204
Submission : 2020-09-29
Status :
Type : II
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API Imports and Exports
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Drugs in Development
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
A Edaravone manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Edaravone, including repackagers and relabelers. The FDA regulates Edaravone manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Edaravone 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 Edaravone manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Edaravone supplier is an individual or a company that provides Edaravone active pharmaceutical ingredient (API) or Edaravone finished formulations upon request. The Edaravone suppliers may include Edaravone API manufacturers, exporters, distributors and traders.
click here to find a list of Edaravone suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Edaravone DMF (Drug Master File) is a document detailing the whole manufacturing process of Edaravone active pharmaceutical ingredient (API) in detail. Different forms of Edaravone DMFs exist exist since differing nations have different regulations, such as Edaravone USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Edaravone DMF submitted to regulatory agencies in the US is known as a USDMF. Edaravone USDMF includes data on Edaravone's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Edaravone USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Edaravone 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 Edaravone Drug Master File in Japan (Edaravone JDMF) empowers Edaravone 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 Edaravone JDMF during the approval evaluation for pharmaceutical products. At the time of Edaravone 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 Edaravone suppliers with JDMF on PharmaCompass.
A Edaravone written confirmation (Edaravone WC) is an official document issued by a regulatory agency to a Edaravone manufacturer, verifying that the manufacturing facility of a Edaravone active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Edaravone APIs or Edaravone finished pharmaceutical products to another nation, regulatory agencies frequently require a Edaravone WC (written confirmation) as part of the regulatory process.
click here to find a list of Edaravone 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 Edaravone as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Edaravone 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 Edaravone 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 Edaravone and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Edaravone NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Edaravone suppliers with NDC on PharmaCompass.
Edaravone 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 Edaravone 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 Edaravone GMP manufacturer or Edaravone GMP API supplier for your needs.
A Edaravone CoA (Certificate of Analysis) is a formal document that attests to Edaravone's compliance with Edaravone specifications and serves as a tool for batch-level quality control.
Edaravone CoA mostly includes findings from lab analyses of a specific batch. For each Edaravone 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.
Edaravone may be tested according to a variety of international standards, such as European Pharmacopoeia (Edaravone EP), Edaravone JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Edaravone USP).
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