Synopsis
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CEP/COS
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VMF
DRUG PRODUCT COMPOSITIONS
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Data Compilation #PharmaFlow
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Stock Recap #PipelineProspector
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Weekly News Recap #Phispers
API SUPPLIERS
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Gonane has API manufacturing expertise in new-age Corticosteroids, Hormones and other pharma raw materials.
HRV Pharma - Market Expansion Leader in Pharmaceuticals.
Shandong Loncom is an R&D-focused manufacturer of Anti-cancer APIs.
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
Lee Fine Chem: Advancing Innovation and Quality in Intermediates, APIs, and Dosage Forms for Superior Pharmaceutical Solutions.
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USDMF
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API Imports and Exports
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Rochem International Inc
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
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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 MALEATE manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of SUNITINIB MALEATE, including repackagers and relabelers. The FDA regulates SUNITINIB MALEATE manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. SUNITINIB MALEATE 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 MALEATE manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A SUNITINIB MALEATE supplier is an individual or a company that provides SUNITINIB MALEATE active pharmaceutical ingredient (API) or SUNITINIB MALEATE finished formulations upon request. The SUNITINIB MALEATE suppliers may include SUNITINIB MALEATE API manufacturers, exporters, distributors and traders.
click here to find a list of SUNITINIB MALEATE suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A SUNITINIB MALEATE DMF (Drug Master File) is a document detailing the whole manufacturing process of SUNITINIB MALEATE active pharmaceutical ingredient (API) in detail. Different forms of SUNITINIB MALEATE DMFs exist exist since differing nations have different regulations, such as SUNITINIB MALEATE USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A SUNITINIB MALEATE DMF submitted to regulatory agencies in the US is known as a USDMF. SUNITINIB MALEATE USDMF includes data on SUNITINIB MALEATE's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The SUNITINIB MALEATE USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of SUNITINIB MALEATE 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 MALEATE Drug Master File in Japan (SUNITINIB MALEATE JDMF) empowers SUNITINIB MALEATE 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 MALEATE JDMF during the approval evaluation for pharmaceutical products. At the time of SUNITINIB MALEATE 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 MALEATE 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 MALEATE Drug Master File in Korea (SUNITINIB MALEATE KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of SUNITINIB MALEATE. The MFDS reviews the SUNITINIB MALEATE KDMF as part of the drug registration process and uses the information provided in the SUNITINIB MALEATE KDMF to evaluate the safety and efficacy of the drug.
After submitting a SUNITINIB MALEATE 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 MALEATE API can apply through the Korea Drug Master File (KDMF).
click here to find a list of SUNITINIB MALEATE suppliers with KDMF on PharmaCompass.
A SUNITINIB MALEATE written confirmation (SUNITINIB MALEATE WC) is an official document issued by a regulatory agency to a SUNITINIB MALEATE manufacturer, verifying that the manufacturing facility of a SUNITINIB MALEATE active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting SUNITINIB MALEATE APIs or SUNITINIB MALEATE finished pharmaceutical products to another nation, regulatory agencies frequently require a SUNITINIB MALEATE WC (written confirmation) as part of the regulatory process.
click here to find a list of SUNITINIB MALEATE 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 MALEATE as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for SUNITINIB MALEATE 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 MALEATE 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 MALEATE and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a SUNITINIB MALEATE NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of SUNITINIB MALEATE suppliers with NDC on PharmaCompass.
SUNITINIB MALEATE 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 MALEATE 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 MALEATE GMP manufacturer or SUNITINIB MALEATE GMP API supplier for your needs.
A SUNITINIB MALEATE CoA (Certificate of Analysis) is a formal document that attests to SUNITINIB MALEATE's compliance with SUNITINIB MALEATE specifications and serves as a tool for batch-level quality control.
SUNITINIB MALEATE CoA mostly includes findings from lab analyses of a specific batch. For each SUNITINIB MALEATE 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 MALEATE may be tested according to a variety of international standards, such as European Pharmacopoeia (SUNITINIB MALEATE EP), SUNITINIB MALEATE JP (Japanese Pharmacopeia) and the US Pharmacopoeia (SUNITINIB MALEATE USP).
