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USDMF
ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
GDUFA
DMF Review : Complete
Rev. Date : 2013-11-01
Pay. Date : 2013-05-07
DMF Number : 26479
Submission : 2013-05-02
Status :
Type : II
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18409
Submission : 2005-06-08
Status :
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-07-30
Pay. Date : 2013-06-24
DMF Number : 25669
Submission : 2012-02-16
Status :
Type : II
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Date of Issue : 2024-04-23
Valid Till : 2027-04-22
Written Confirmation Number : WC-0170
Address of the Firm : Plot No. 41, 42/2, 42/1/B, 43, 40, 59, 58 GIDC, Vapi, Dist: Valsad -396195, Guja...
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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 Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Dronedarone Hydrochloride, including repackagers and relabelers. The FDA regulates Dronedarone Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Dronedarone Hydrochloride 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 Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Dronedarone Hydrochloride supplier is an individual or a company that provides Dronedarone Hydrochloride active pharmaceutical ingredient (API) or Dronedarone Hydrochloride finished formulations upon request. The Dronedarone Hydrochloride suppliers may include Dronedarone Hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Dronedarone Hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Dronedarone Hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Dronedarone Hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of Dronedarone Hydrochloride DMFs exist exist since differing nations have different regulations, such as Dronedarone Hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Dronedarone Hydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. Dronedarone Hydrochloride USDMF includes data on Dronedarone Hydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Dronedarone Hydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Dronedarone Hydrochloride suppliers with USDMF on PharmaCompass.
A Dronedarone Hydrochloride CEP of the European Pharmacopoeia monograph is often referred to as a Dronedarone Hydrochloride Certificate of Suitability (COS). The purpose of a Dronedarone Hydrochloride CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Dronedarone Hydrochloride EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Dronedarone Hydrochloride to their clients by showing that a Dronedarone Hydrochloride CEP has been issued for it. The manufacturer submits a Dronedarone Hydrochloride CEP (COS) as part of the market authorization procedure, and it takes on the role of a Dronedarone Hydrochloride CEP holder for the record. Additionally, the data presented in the Dronedarone Hydrochloride CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Dronedarone Hydrochloride DMF.
A Dronedarone Hydrochloride CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Dronedarone Hydrochloride 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 Hydrochloride suppliers with CEP (COS) on PharmaCompass.
A Dronedarone Hydrochloride written confirmation (Dronedarone Hydrochloride WC) is an official document issued by a regulatory agency to a Dronedarone Hydrochloride manufacturer, verifying that the manufacturing facility of a Dronedarone Hydrochloride active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Dronedarone Hydrochloride APIs or Dronedarone Hydrochloride finished pharmaceutical products to another nation, regulatory agencies frequently require a Dronedarone Hydrochloride WC (written confirmation) as part of the regulatory process.
click here to find a list of Dronedarone Hydrochloride 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 Hydrochloride as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Dronedarone Hydrochloride 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 Hydrochloride 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 Hydrochloride and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Dronedarone Hydrochloride NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Dronedarone Hydrochloride suppliers with NDC on PharmaCompass.
Dronedarone Hydrochloride 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 Hydrochloride 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 Hydrochloride GMP manufacturer or Dronedarone Hydrochloride GMP API supplier for your needs.
A Dronedarone Hydrochloride CoA (Certificate of Analysis) is a formal document that attests to Dronedarone Hydrochloride's compliance with Dronedarone Hydrochloride specifications and serves as a tool for batch-level quality control.
Dronedarone Hydrochloride CoA mostly includes findings from lab analyses of a specific batch. For each Dronedarone Hydrochloride 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 Hydrochloride may be tested according to a variety of international standards, such as European Pharmacopoeia (Dronedarone Hydrochloride EP), Dronedarone Hydrochloride JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Dronedarone Hydrochloride USP).
