X
API Suppliers
US DMFs Filed
CEP/COS Certifications
0
JDMFs Filed
Other Certificates
Other Suppliers
USA (Orange Book)
Europe
Canada
Australia
South Africa
Uploaded Dossiers
U.S. Medicaid
Annual Reports
55
PharmaCompass offers a list of Sunitinib 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 Sunitinib manufacturer or Sunitinib supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Sunitinib manufacturer or Sunitinib supplier.
PharmaCompass also assists you with knowing the Sunitinib API Price utilized in the formulation of products. Sunitinib API Price is not always fixed or binding as the Sunitinib Price is obtained through a variety of data sources. The Sunitinib Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Sunitinib manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Sunitinib, including repackagers and relabelers. The FDA regulates Sunitinib manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Sunitinib 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 Sunitinib manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Sunitinib supplier is an individual or a company that provides Sunitinib active pharmaceutical ingredient (API) or Sunitinib finished formulations upon request. The Sunitinib suppliers may include Sunitinib API manufacturers, exporters, distributors and traders.
click here to find a list of Sunitinib suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Sunitinib DMF (Drug Master File) is a document detailing the whole manufacturing process of Sunitinib active pharmaceutical ingredient (API) in detail. Different forms of Sunitinib DMFs exist exist since differing nations have different regulations, such as Sunitinib USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Sunitinib DMF submitted to regulatory agencies in the US is known as a USDMF. Sunitinib USDMF includes data on Sunitinib's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Sunitinib USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Sunitinib 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 Sunitinib Drug Master File in Japan (Sunitinib JDMF) empowers Sunitinib 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 Sunitinib JDMF during the approval evaluation for pharmaceutical products. At the time of Sunitinib 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 Sunitinib 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 Sunitinib Drug Master File in Korea (Sunitinib KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Sunitinib. The MFDS reviews the Sunitinib KDMF as part of the drug registration process and uses the information provided in the Sunitinib KDMF to evaluate the safety and efficacy of the drug.
After submitting a Sunitinib 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 Sunitinib API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Sunitinib suppliers with KDMF on PharmaCompass.
A Sunitinib written confirmation (Sunitinib WC) is an official document issued by a regulatory agency to a Sunitinib manufacturer, verifying that the manufacturing facility of a Sunitinib active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Sunitinib APIs or Sunitinib finished pharmaceutical products to another nation, regulatory agencies frequently require a Sunitinib WC (written confirmation) as part of the regulatory process.
click here to find a list of Sunitinib 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 Sunitinib as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Sunitinib 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 Sunitinib 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 Sunitinib and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Sunitinib NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Sunitinib suppliers with NDC on PharmaCompass.
Sunitinib 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 Sunitinib 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 Sunitinib GMP manufacturer or Sunitinib GMP API supplier for your needs.
A Sunitinib CoA (Certificate of Analysis) is a formal document that attests to Sunitinib's compliance with Sunitinib specifications and serves as a tool for batch-level quality control.
Sunitinib CoA mostly includes findings from lab analyses of a specific batch. For each Sunitinib 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.
Sunitinib may be tested according to a variety of international standards, such as European Pharmacopoeia (Sunitinib EP), Sunitinib JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Sunitinib USP).
Market Place
