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South Africa
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Interquim comes from an international group of 50 companies active in the pharma, hospital, diagnostics, fine chemicals & feed sectors.
About the Company : Interquim, founded in 1978 and part of Ferrer HealthTech, develops high-value APIs with strict quality standards. Its facilities comply with European regulations, and products are ...
ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
About the Company : ChemWerth, established in 1982, is a US-headquartered full-service generic API company. It supplies cGMP-quality APIs to regulated markets worldwide, with exclusive partnerships fo...
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
About the Company : Biophore, founded in 2007, develops and manufactures niche and complex pharmaceutical products. With USFDA- and EU-approved API facilities, a dedicated intermediates site and an R&...
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
About the Company : LGM Pharma is a global leader in sourcing APIs, including hard-to-find drug substances, for pharmaceutical and biotech industries. LGM also operates as a full-service drug product ...
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
About the Company : Established in 2004, Metrochem API is one of the fastest-growing APIs, pellets & intermediates manufacturers. It has 6 dedicated manufacturing facilities for its 3 core product gro...
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...
Neuland Laboratories- A dedicated 100% API provider.
About the Company : Neuland Laboratories, established in 1984 and headquartered in Hyderabad, is a publicly listed company offering solutions for pharmaceutical chemistry needs—from library compound...
Sumar Biotech work together to Innovate & Manufacture Semi-synthetic, Synthetic & Fermentation API.
About the Company : Sumar Biotech LLP, registered in January 2018, is a startup approved by the Gujarat State Biotechnology Mission. Founded by young entrepreneurs and experienced research and manufac...
Honour is a leading global CDMO and specialty chemicals manufacturer with seven world-class sites delivering quality-driven solutions.
About the Company : Honour is a leading global CDMO and trusted manufacturer of specialty chemicals and ingredients, with seven world-class facilities meeting global safety and quality standards. Thro...
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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, and more, enabling you to easily find the right Edaravone manufacturer or Edaravone supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Edaravone manufacturer or Edaravone supplier.
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.
click here to find a list of 1 Phenyl 3 methyl 5 pyrazolone manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
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.
click here to find a list of 1 Phenyl 3 methyl 5 pyrazolone suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
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.
click here to find a list of 1 Phenyl 3 methyl 5 pyrazolone 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 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.
click here to find a list of 1 Phenyl 3 methyl 5 pyrazolone suppliers with JDMF on PharmaCompass.
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.
click here to find a list of 1 Phenyl 3 methyl 5 pyrazolone 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 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.
click here to find a list of 1 Phenyl 3 methyl 5 pyrazolone suppliers with NDC on PharmaCompass.
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, 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).
