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