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