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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 HCl manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Dronedarone HCl, including repackagers and relabelers. The FDA regulates Dronedarone HCl manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Dronedarone HCl 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 HCl manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Dronedarone HCl supplier is an individual or a company that provides Dronedarone HCl active pharmaceutical ingredient (API) or Dronedarone HCl finished formulations upon request. The Dronedarone HCl suppliers may include Dronedarone HCl API manufacturers, exporters, distributors and traders.
click here to find a list of Dronedarone HCl suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Dronedarone HCl DMF (Drug Master File) is a document detailing the whole manufacturing process of Dronedarone HCl active pharmaceutical ingredient (API) in detail. Different forms of Dronedarone HCl DMFs exist exist since differing nations have different regulations, such as Dronedarone HCl USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Dronedarone HCl DMF submitted to regulatory agencies in the US is known as a USDMF. Dronedarone HCl USDMF includes data on Dronedarone HCl's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Dronedarone HCl USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Dronedarone HCl 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 HCl Drug Master File in Korea (Dronedarone HCl KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Dronedarone HCl. The MFDS reviews the Dronedarone HCl KDMF as part of the drug registration process and uses the information provided in the Dronedarone HCl KDMF to evaluate the safety and efficacy of the drug.
After submitting a Dronedarone HCl 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 HCl API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Dronedarone HCl suppliers with KDMF on PharmaCompass.
A Dronedarone HCl CEP of the European Pharmacopoeia monograph is often referred to as a Dronedarone HCl Certificate of Suitability (COS). The purpose of a Dronedarone HCl CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Dronedarone HCl EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Dronedarone HCl to their clients by showing that a Dronedarone HCl CEP has been issued for it. The manufacturer submits a Dronedarone HCl CEP (COS) as part of the market authorization procedure, and it takes on the role of a Dronedarone HCl CEP holder for the record. Additionally, the data presented in the Dronedarone HCl CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Dronedarone HCl DMF.
A Dronedarone HCl CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Dronedarone HCl 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 HCl suppliers with CEP (COS) on PharmaCompass.
A Dronedarone HCl written confirmation (Dronedarone HCl WC) is an official document issued by a regulatory agency to a Dronedarone HCl manufacturer, verifying that the manufacturing facility of a Dronedarone HCl active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Dronedarone HCl APIs or Dronedarone HCl finished pharmaceutical products to another nation, regulatory agencies frequently require a Dronedarone HCl WC (written confirmation) as part of the regulatory process.
click here to find a list of Dronedarone HCl 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 HCl as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Dronedarone HCl 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 HCl 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 HCl and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Dronedarone HCl NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Dronedarone HCl suppliers with NDC on PharmaCompass.
Dronedarone HCl 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 HCl 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 HCl GMP manufacturer or Dronedarone HCl GMP API supplier for your needs.
A Dronedarone HCl CoA (Certificate of Analysis) is a formal document that attests to Dronedarone HCl's compliance with Dronedarone HCl specifications and serves as a tool for batch-level quality control.
Dronedarone HCl CoA mostly includes findings from lab analyses of a specific batch. For each Dronedarone HCl 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 HCl may be tested according to a variety of international standards, such as European Pharmacopoeia (Dronedarone HCl EP), Dronedarone HCl JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Dronedarone HCl USP).
