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