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