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PharmaCompass offers a list of Sorafenib 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 Sorafenib manufacturer or Sorafenib supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Sorafenib manufacturer or Sorafenib supplier.
PharmaCompass also assists you with knowing the Sorafenib API Price utilized in the formulation of products. Sorafenib API Price is not always fixed or binding as the Sorafenib Price is obtained through a variety of data sources. The Sorafenib Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Nexavar manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Nexavar, including repackagers and relabelers. The FDA regulates Nexavar manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Nexavar 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 Nexavar manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Nexavar supplier is an individual or a company that provides Nexavar active pharmaceutical ingredient (API) or Nexavar finished formulations upon request. The Nexavar suppliers may include Nexavar API manufacturers, exporters, distributors and traders.
click here to find a list of Nexavar suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Nexavar DMF (Drug Master File) is a document detailing the whole manufacturing process of Nexavar active pharmaceutical ingredient (API) in detail. Different forms of Nexavar DMFs exist exist since differing nations have different regulations, such as Nexavar USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Nexavar DMF submitted to regulatory agencies in the US is known as a USDMF. Nexavar USDMF includes data on Nexavar's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Nexavar USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Nexavar 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 Nexavar Drug Master File in Japan (Nexavar JDMF) empowers Nexavar 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 Nexavar JDMF during the approval evaluation for pharmaceutical products. At the time of Nexavar 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 Nexavar 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 Nexavar Drug Master File in Korea (Nexavar KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Nexavar. The MFDS reviews the Nexavar KDMF as part of the drug registration process and uses the information provided in the Nexavar KDMF to evaluate the safety and efficacy of the drug.
After submitting a Nexavar 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 Nexavar API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Nexavar suppliers with KDMF on PharmaCompass.
A Nexavar CEP of the European Pharmacopoeia monograph is often referred to as a Nexavar Certificate of Suitability (COS). The purpose of a Nexavar CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Nexavar EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Nexavar to their clients by showing that a Nexavar CEP has been issued for it. The manufacturer submits a Nexavar CEP (COS) as part of the market authorization procedure, and it takes on the role of a Nexavar CEP holder for the record. Additionally, the data presented in the Nexavar CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Nexavar DMF.
A Nexavar CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Nexavar CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
click here to find a list of Nexavar suppliers with CEP (COS) on PharmaCompass.
A Nexavar written confirmation (Nexavar WC) is an official document issued by a regulatory agency to a Nexavar manufacturer, verifying that the manufacturing facility of a Nexavar active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Nexavar APIs or Nexavar finished pharmaceutical products to another nation, regulatory agencies frequently require a Nexavar WC (written confirmation) as part of the regulatory process.
click here to find a list of Nexavar 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 Nexavar as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Nexavar 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 Nexavar 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 Nexavar and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Nexavar NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Nexavar suppliers with NDC on PharmaCompass.
Nexavar 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 Nexavar 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 Nexavar GMP manufacturer or Nexavar GMP API supplier for your needs.
A Nexavar CoA (Certificate of Analysis) is a formal document that attests to Nexavar's compliance with Nexavar specifications and serves as a tool for batch-level quality control.
Nexavar CoA mostly includes findings from lab analyses of a specific batch. For each Nexavar 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.
Nexavar may be tested according to a variety of international standards, such as European Pharmacopoeia (Nexavar EP), Nexavar JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Nexavar USP).
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