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