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