Synopsis
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CEP/COS
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KDMF
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VMF
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South Africa
DRUG PRODUCT COMPOSITIONS
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Data Compilation #PharmaFlow
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Stock Recap #PipelineProspector
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Weekly News Recap #Phispers
API SUPPLIERS
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USDMF
Medichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.
GDUFA
DMF Review : Complete
Rev. Date : 2013-02-26
Pay. Date : 2013-02-05
DMF Number : 8590
Submission : 1990-06-12
Status :
Type : II
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API/FDF Prices: Book a Demo to explore the features and consider upgrading later
API Imports and Exports
INTERMEDIATE SUPPLIERS
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ABOUT THIS PAGE
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PharmaCompass offers a list of Guanfacine 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 Guanfacine manufacturer or Guanfacine supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Guanfacine manufacturer or Guanfacine supplier.
PharmaCompass also assists you with knowing the Guanfacine API Price utilized in the formulation of products. Guanfacine API Price is not always fixed or binding as the Guanfacine Price is obtained through a variety of data sources. The Guanfacine Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Guanfacine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Guanfacine, including repackagers and relabelers. The FDA regulates Guanfacine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Guanfacine 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 Guanfacine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Guanfacine supplier is an individual or a company that provides Guanfacine active pharmaceutical ingredient (API) or Guanfacine finished formulations upon request. The Guanfacine suppliers may include Guanfacine API manufacturers, exporters, distributors and traders.
click here to find a list of Guanfacine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Guanfacine DMF (Drug Master File) is a document detailing the whole manufacturing process of Guanfacine active pharmaceutical ingredient (API) in detail. Different forms of Guanfacine DMFs exist exist since differing nations have different regulations, such as Guanfacine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Guanfacine DMF submitted to regulatory agencies in the US is known as a USDMF. Guanfacine USDMF includes data on Guanfacine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Guanfacine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Guanfacine 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 Guanfacine Drug Master File in Japan (Guanfacine JDMF) empowers Guanfacine 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 Guanfacine JDMF during the approval evaluation for pharmaceutical products. At the time of Guanfacine 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 Guanfacine suppliers with JDMF on PharmaCompass.
A Guanfacine written confirmation (Guanfacine WC) is an official document issued by a regulatory agency to a Guanfacine manufacturer, verifying that the manufacturing facility of a Guanfacine active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Guanfacine APIs or Guanfacine finished pharmaceutical products to another nation, regulatory agencies frequently require a Guanfacine WC (written confirmation) as part of the regulatory process.
click here to find a list of Guanfacine 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 Guanfacine as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Guanfacine 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 Guanfacine 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 Guanfacine and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Guanfacine NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Guanfacine suppliers with NDC on PharmaCompass.
Guanfacine 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 Guanfacine 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 Guanfacine GMP manufacturer or Guanfacine GMP API supplier for your needs.
A Guanfacine CoA (Certificate of Analysis) is a formal document that attests to Guanfacine's compliance with Guanfacine specifications and serves as a tool for batch-level quality control.
Guanfacine CoA mostly includes findings from lab analyses of a specific batch. For each Guanfacine 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.
Guanfacine may be tested according to a variety of international standards, such as European Pharmacopoeia (Guanfacine EP), Guanfacine JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Guanfacine USP).
