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USDMF
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SPI Pharma
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ABOUT THIS PAGE
34
PharmaCompass offers a list of Dronedarone Hydrochloride 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 Dronedarone Hydrochloride manufacturer or Dronedarone Hydrochloride supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Dronedarone Hydrochloride manufacturer or Dronedarone Hydrochloride supplier.
PharmaCompass also assists you with knowing the Dronedarone Hydrochloride API Price utilized in the formulation of products. Dronedarone Hydrochloride API Price is not always fixed or binding as the Dronedarone Hydrochloride Price is obtained through a variety of data sources. The Dronedarone Hydrochloride Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Dronedarone manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Dronedarone, including repackagers and relabelers. The FDA regulates Dronedarone manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Dronedarone 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 Dronedarone manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Dronedarone supplier is an individual or a company that provides Dronedarone active pharmaceutical ingredient (API) or Dronedarone finished formulations upon request. The Dronedarone suppliers may include Dronedarone API manufacturers, exporters, distributors and traders.
click here to find a list of Dronedarone suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Dronedarone DMF (Drug Master File) is a document detailing the whole manufacturing process of Dronedarone active pharmaceutical ingredient (API) in detail. Different forms of Dronedarone DMFs exist exist since differing nations have different regulations, such as Dronedarone USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Dronedarone DMF submitted to regulatory agencies in the US is known as a USDMF. Dronedarone USDMF includes data on Dronedarone's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Dronedarone USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Dronedarone suppliers with USDMF on PharmaCompass.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Dronedarone Drug Master File in Korea (Dronedarone KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Dronedarone. The MFDS reviews the Dronedarone KDMF as part of the drug registration process and uses the information provided in the Dronedarone KDMF to evaluate the safety and efficacy of the drug.
After submitting a Dronedarone KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Dronedarone API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Dronedarone suppliers with KDMF on PharmaCompass.
A Dronedarone CEP of the European Pharmacopoeia monograph is often referred to as a Dronedarone Certificate of Suitability (COS). The purpose of a Dronedarone CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Dronedarone EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Dronedarone to their clients by showing that a Dronedarone CEP has been issued for it. The manufacturer submits a Dronedarone CEP (COS) as part of the market authorization procedure, and it takes on the role of a Dronedarone CEP holder for the record. Additionally, the data presented in the Dronedarone CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Dronedarone DMF.
A Dronedarone CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Dronedarone 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 Dronedarone suppliers with CEP (COS) on PharmaCompass.
A Dronedarone written confirmation (Dronedarone WC) is an official document issued by a regulatory agency to a Dronedarone manufacturer, verifying that the manufacturing facility of a Dronedarone active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Dronedarone APIs or Dronedarone finished pharmaceutical products to another nation, regulatory agencies frequently require a Dronedarone WC (written confirmation) as part of the regulatory process.
click here to find a list of Dronedarone 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 Dronedarone as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Dronedarone 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 Dronedarone 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 Dronedarone and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Dronedarone NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Dronedarone suppliers with NDC on PharmaCompass.
Dronedarone 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 Dronedarone 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 Dronedarone GMP manufacturer or Dronedarone GMP API supplier for your needs.
A Dronedarone CoA (Certificate of Analysis) is a formal document that attests to Dronedarone's compliance with Dronedarone specifications and serves as a tool for batch-level quality control.
Dronedarone CoA mostly includes findings from lab analyses of a specific batch. For each Dronedarone 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.
Dronedarone may be tested according to a variety of international standards, such as European Pharmacopoeia (Dronedarone EP), Dronedarone JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Dronedarone USP).
