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