Synopsis
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KDMF
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VMF
DRUG PRODUCT COMPOSITIONS
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US Patents
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US Exclusivities
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Health Canada Patents
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Stock Recap #PipelineProspector
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Weekly News Recap #Phispers
API SUPPLIERS
Minakem delivers API, HPAPI, steroids & CDMO services for generics with FDA/GMP certification, regulatory know-how & proven success.
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NDC
Minakem is manufacturing small molecules APIs including corticosteroids
Aspen API. More than just an API™
ASMF
JDMF
NDC
Zeon Pharma is a manufacturer and supplier of APIs & Intermediates.
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USDMF
Minakem delivers API, HPAPI, steroids & CDMO services for generics with FDA/GMP certification, regulatory know-how & proven success.
GDUFA
DMF Review : Complete
Rev. Date : 2021-10-25
Pay. Date : 2021-10-21
DMF Number : 4932
Submission : 1983-06-01
Status :
Type : II
Aspen API. More than just an API™
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4561
Submission : 1982-05-12
Status :
Type : II
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]CEP/COS
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results] JDMF
Registration Number : 306MF10067
Registrant's Address : 15 Hawkins Avenue, Epping 1,7460, Cape Town, South Africa
Initial Date of Registration : 2024-05-15
Latest Date of Registration : 2024-05-15
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API/FDF Prices: Book a Demo to explore the features and consider upgrading later
API Imports and Exports
Drugs in Development
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Related Excipient Companies
Rochem International Inc
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Shanghai Shenmei Pharmaceutical Technology Co., Ltd
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Chewable & Orodispersible Aids
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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 Vintec manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Vintec, including repackagers and relabelers. The FDA regulates Vintec manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Vintec 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 Vintec manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Vintec supplier is an individual or a company that provides Vintec active pharmaceutical ingredient (API) or Vintec finished formulations upon request. The Vintec suppliers may include Vintec API manufacturers, exporters, distributors and traders.
click here to find a list of Vintec suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Vintec DMF (Drug Master File) is a document detailing the whole manufacturing process of Vintec active pharmaceutical ingredient (API) in detail. Different forms of Vintec DMFs exist exist since differing nations have different regulations, such as Vintec USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Vintec DMF submitted to regulatory agencies in the US is known as a USDMF. Vintec USDMF includes data on Vintec's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Vintec USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Vintec 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 Vintec Drug Master File in Japan (Vintec JDMF) empowers Vintec 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 Vintec JDMF during the approval evaluation for pharmaceutical products. At the time of Vintec 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 Vintec suppliers with JDMF on PharmaCompass.
A Vintec CEP of the European Pharmacopoeia monograph is often referred to as a Vintec Certificate of Suitability (COS). The purpose of a Vintec CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Vintec EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Vintec to their clients by showing that a Vintec CEP has been issued for it. The manufacturer submits a Vintec CEP (COS) as part of the market authorization procedure, and it takes on the role of a Vintec CEP holder for the record. Additionally, the data presented in the Vintec CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Vintec DMF.
A Vintec CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Vintec 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 Vintec suppliers with CEP (COS) on PharmaCompass.
A Vintec written confirmation (Vintec WC) is an official document issued by a regulatory agency to a Vintec manufacturer, verifying that the manufacturing facility of a Vintec active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Vintec APIs or Vintec finished pharmaceutical products to another nation, regulatory agencies frequently require a Vintec WC (written confirmation) as part of the regulatory process.
click here to find a list of Vintec 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 Vintec as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Vintec 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 Vintec 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 Vintec and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Vintec NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Vintec suppliers with NDC on PharmaCompass.
Vintec 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 Vintec 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 Vintec GMP manufacturer or Vintec GMP API supplier for your needs.
A Vintec CoA (Certificate of Analysis) is a formal document that attests to Vintec's compliance with Vintec specifications and serves as a tool for batch-level quality control.
Vintec CoA mostly includes findings from lab analyses of a specific batch. For each Vintec 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.
Vintec may be tested according to a variety of international standards, such as European Pharmacopoeia (Vintec EP), Vintec JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Vintec USP).
