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PharmaCompass offers a list of Edaravone 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 Edaravone manufacturer or Edaravone supplier for your needs.
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PharmaCompass also assists you with knowing the Edaravone API Price utilized in the formulation of products. Edaravone API Price is not always fixed or binding as the Edaravone Price is obtained through a variety of data sources. The Edaravone Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A 1 Phenyl 3 methyl 5 pyrazolone manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of 1 Phenyl 3 methyl 5 pyrazolone, including repackagers and relabelers. The FDA regulates 1 Phenyl 3 methyl 5 pyrazolone manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. 1 Phenyl 3 methyl 5 pyrazolone API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A 1 Phenyl 3 methyl 5 pyrazolone supplier is an individual or a company that provides 1 Phenyl 3 methyl 5 pyrazolone active pharmaceutical ingredient (API) or 1 Phenyl 3 methyl 5 pyrazolone finished formulations upon request. The 1 Phenyl 3 methyl 5 pyrazolone suppliers may include 1 Phenyl 3 methyl 5 pyrazolone API manufacturers, exporters, distributors and traders.
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A 1 Phenyl 3 methyl 5 pyrazolone DMF (Drug Master File) is a document detailing the whole manufacturing process of 1 Phenyl 3 methyl 5 pyrazolone active pharmaceutical ingredient (API) in detail. Different forms of 1 Phenyl 3 methyl 5 pyrazolone DMFs exist exist since differing nations have different regulations, such as 1 Phenyl 3 methyl 5 pyrazolone USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A 1 Phenyl 3 methyl 5 pyrazolone DMF submitted to regulatory agencies in the US is known as a USDMF. 1 Phenyl 3 methyl 5 pyrazolone USDMF includes data on 1 Phenyl 3 methyl 5 pyrazolone's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The 1 Phenyl 3 methyl 5 pyrazolone USDMF is kept confidential to protect the manufacturer’s intellectual property.
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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 1 Phenyl 3 methyl 5 pyrazolone Drug Master File in Japan (1 Phenyl 3 methyl 5 pyrazolone JDMF) empowers 1 Phenyl 3 methyl 5 pyrazolone 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 1 Phenyl 3 methyl 5 pyrazolone JDMF during the approval evaluation for pharmaceutical products. At the time of 1 Phenyl 3 methyl 5 pyrazolone JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
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In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a 1 Phenyl 3 methyl 5 pyrazolone Drug Master File in Korea (1 Phenyl 3 methyl 5 pyrazolone KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of 1 Phenyl 3 methyl 5 pyrazolone. The MFDS reviews the 1 Phenyl 3 methyl 5 pyrazolone KDMF as part of the drug registration process and uses the information provided in the 1 Phenyl 3 methyl 5 pyrazolone KDMF to evaluate the safety and efficacy of the drug.
After submitting a 1 Phenyl 3 methyl 5 pyrazolone 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 1 Phenyl 3 methyl 5 pyrazolone API can apply through the Korea Drug Master File (KDMF).
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A 1 Phenyl 3 methyl 5 pyrazolone written confirmation (1 Phenyl 3 methyl 5 pyrazolone WC) is an official document issued by a regulatory agency to a 1 Phenyl 3 methyl 5 pyrazolone manufacturer, verifying that the manufacturing facility of a 1 Phenyl 3 methyl 5 pyrazolone active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting 1 Phenyl 3 methyl 5 pyrazolone APIs or 1 Phenyl 3 methyl 5 pyrazolone finished pharmaceutical products to another nation, regulatory agencies frequently require a 1 Phenyl 3 methyl 5 pyrazolone WC (written confirmation) as part of the regulatory process.
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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 1 Phenyl 3 methyl 5 pyrazolone as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for 1 Phenyl 3 methyl 5 pyrazolone 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 1 Phenyl 3 methyl 5 pyrazolone 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 1 Phenyl 3 methyl 5 pyrazolone and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a 1 Phenyl 3 methyl 5 pyrazolone NDC to their finished compounded human drug products, they may choose to do so.
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1 Phenyl 3 methyl 5 pyrazolone 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 1 Phenyl 3 methyl 5 pyrazolone 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 1 Phenyl 3 methyl 5 pyrazolone GMP manufacturer or 1 Phenyl 3 methyl 5 pyrazolone GMP API supplier for your needs.
A 1 Phenyl 3 methyl 5 pyrazolone CoA (Certificate of Analysis) is a formal document that attests to 1 Phenyl 3 methyl 5 pyrazolone's compliance with 1 Phenyl 3 methyl 5 pyrazolone specifications and serves as a tool for batch-level quality control.
1 Phenyl 3 methyl 5 pyrazolone CoA mostly includes findings from lab analyses of a specific batch. For each 1 Phenyl 3 methyl 5 pyrazolone 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.
1 Phenyl 3 methyl 5 pyrazolone may be tested according to a variety of international standards, such as European Pharmacopoeia (1 Phenyl 3 methyl 5 pyrazolone EP), 1 Phenyl 3 methyl 5 pyrazolone JP (Japanese Pharmacopeia) and the US Pharmacopoeia (1 Phenyl 3 methyl 5 pyrazolone USP).
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