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