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