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