US DMFs Filed
USA (Orange Book)
PharmaCompass offers a list of Propafenone 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 Propafenone manufacturer or Propafenone supplier for your needs.
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PharmaCompass also assists you with knowing the Propafenone API Price utilized in the formulation of products. Propafenone API Price is not always fixed or binding as the Propafenone Price is obtained through a variety of data sources. The Propafenone Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Propafenone Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Propafenone Hydrochloride, including repackagers and relabelers. The FDA regulates Propafenone Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Propafenone 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 Propafenone Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Propafenone Hydrochloride supplier is an individual or a company that provides Propafenone Hydrochloride active pharmaceutical ingredient (API) or Propafenone Hydrochloride finished formulations upon request. The Propafenone Hydrochloride suppliers may include Propafenone Hydrochloride API manufacturers, exporters, distributors and traders.
CLICK HERE to find a list of Propafenone Hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Propafenone Hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Propafenone Hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of Propafenone Hydrochloride DMFs exist exist since differing nations have different regulations, such as Propafenone Hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Propafenone Hydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. Propafenone Hydrochloride USDMF includes data on Propafenone Hydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Propafenone Hydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.
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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 Propafenone Hydrochloride Drug Master File in Japan (Propafenone Hydrochloride JDMF) empowers Propafenone Hydrochloride 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 Propafenone Hydrochloride JDMF during the approval evaluation for pharmaceutical products. At the time of Propafenone Hydrochloride JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
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In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Propafenone Hydrochloride Drug Master File in Korea (Propafenone Hydrochloride KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Propafenone Hydrochloride. The MFDS reviews the Propafenone Hydrochloride KDMF as part of the drug registration process and uses the information provided in the Propafenone Hydrochloride KDMF to evaluate the safety and efficacy of the drug.
After submitting a Propafenone Hydrochloride 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 Propafenone Hydrochloride API can apply through the Korea Drug Master File (KDMF).
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A Propafenone Hydrochloride CEP of the European Pharmacopoeia monograph is often referred to as a Propafenone Hydrochloride Certificate of Suitability (COS). The purpose of a Propafenone Hydrochloride CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Propafenone Hydrochloride EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Propafenone Hydrochloride to their clients by showing that a Propafenone Hydrochloride CEP has been issued for it. The manufacturer submits a Propafenone Hydrochloride CEP (COS) as part of the market authorization procedure, and it takes on the role of a Propafenone Hydrochloride CEP holder for the record. Additionally, the data presented in the Propafenone Hydrochloride CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Propafenone Hydrochloride DMF.
A Propafenone Hydrochloride CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Propafenone Hydrochloride CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
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A Propafenone Hydrochloride written confirmation (Propafenone Hydrochloride WC) is an official document issued by a regulatory agency to a Propafenone Hydrochloride manufacturer, verifying that the manufacturing facility of a Propafenone Hydrochloride active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Propafenone Hydrochloride APIs or Propafenone Hydrochloride finished pharmaceutical products to another nation, regulatory agencies frequently require a Propafenone Hydrochloride WC (written confirmation) as part of the regulatory process.
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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 Propafenone Hydrochloride as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Propafenone 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 Propafenone 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 Propafenone Hydrochloride and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Propafenone Hydrochloride NDC to their finished compounded human drug products, they may choose to do so.
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Propafenone 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 Propafenone 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 Propafenone Hydrochloride GMP manufacturer or Propafenone Hydrochloride GMP API supplier for your needs.
A Propafenone Hydrochloride CoA (Certificate of Analysis) is a formal document that attests to Propafenone Hydrochloride's compliance with Propafenone Hydrochloride specifications and serves as a tool for batch-level quality control.
Propafenone Hydrochloride CoA mostly includes findings from lab analyses of a specific batch. For each Propafenone 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.
Propafenone Hydrochloride may be tested according to a variety of international standards, such as European Pharmacopoeia (Propafenone Hydrochloride EP), Propafenone Hydrochloride JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Propafenone Hydrochloride USP).