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