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CEP/COS
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JDMF
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KDMF
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VMF
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Europe
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Canada
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Australia
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South Africa
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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Data Compilation #PharmaFlow
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Stock Recap #PipelineProspector
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Weekly News Recap #Phispers
API SUPPLIERS
Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
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Aarti Pharmalabs is a partner of choice for APIs & Intermediates and the largest Indian manufacturer of Xanthine Derivatives.
EU-WC
NDC
ASMF
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USDMF
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Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
About the Company : Cohance Lifesciences is a leading CDMO and API platform, offering products and services across all phases of a molecule’s lifecycle from development to commercialzation. With our...
Aarti Pharmalabs is a partner of choice for APIs & Intermediates and the largest Indian manufacturer of Xanthine Derivatives.
About the Company : Aarti Pharmalab, earlier the pharma division of Aarti Industries, is a leading Indian manufacturer of APIs. It has dedicated facilities to manufacture HPAPIs, corticosteroids, cyto...
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INTERMEDIATES SUPPLIERS
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
A Diflunisal manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Diflunisal, including repackagers and relabelers. The FDA regulates Diflunisal manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Diflunisal 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 Diflunisal manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Diflunisal supplier is an individual or a company that provides Diflunisal active pharmaceutical ingredient (API) or Diflunisal finished formulations upon request. The Diflunisal suppliers may include Diflunisal API manufacturers, exporters, distributors and traders.
click here to find a list of Diflunisal suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Diflunisal DMF (Drug Master File) is a document detailing the whole manufacturing process of Diflunisal active pharmaceutical ingredient (API) in detail. Different forms of Diflunisal DMFs exist exist since differing nations have different regulations, such as Diflunisal USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Diflunisal DMF submitted to regulatory agencies in the US is known as a USDMF. Diflunisal USDMF includes data on Diflunisal's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Diflunisal USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Diflunisal suppliers with USDMF on PharmaCompass.
A Diflunisal written confirmation (Diflunisal WC) is an official document issued by a regulatory agency to a Diflunisal manufacturer, verifying that the manufacturing facility of a Diflunisal active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Diflunisal APIs or Diflunisal finished pharmaceutical products to another nation, regulatory agencies frequently require a Diflunisal WC (written confirmation) as part of the regulatory process.
click here to find a list of Diflunisal 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 Diflunisal as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Diflunisal 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 Diflunisal 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 Diflunisal and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Diflunisal NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Diflunisal suppliers with NDC on PharmaCompass.
Diflunisal 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 Diflunisal 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 Diflunisal GMP manufacturer or Diflunisal GMP API supplier for your needs.
A Diflunisal CoA (Certificate of Analysis) is a formal document that attests to Diflunisal's compliance with Diflunisal specifications and serves as a tool for batch-level quality control.
Diflunisal CoA mostly includes findings from lab analyses of a specific batch. For each Diflunisal 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.
Diflunisal may be tested according to a variety of international standards, such as European Pharmacopoeia (Diflunisal EP), Diflunisal JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Diflunisal USP).
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