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DOSAGE - TABLET;ORAL - 150MG **Federal Regist...DOSAGE - TABLET;ORAL - 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 19151
DOSAGE - TABLET;ORAL - 225MG **Federal Regist...DOSAGE - TABLET;ORAL - 225MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 19151
DOSAGE - TABLET;ORAL - 300MG **Federal Regist...DOSAGE - TABLET;ORAL - 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 19151
DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 225...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 225MG
USFDA APPLICATION NUMBER - 21416
DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 325...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 325MG
USFDA APPLICATION NUMBER - 21416
DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 425...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 425MG
USFDA APPLICATION NUMBER - 21416
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ABOUT THIS PAGE
56
PharmaCompass offers a list of Propafenone 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 Propafenone Hydrochloride manufacturer or Propafenone Hydrochloride supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Propafenone Hydrochloride manufacturer or Propafenone Hydrochloride supplier.
PharmaCompass also assists you with knowing the Propafenone Hydrochloride API Price utilized in the formulation of products. Propafenone Hydrochloride API Price is not always fixed or binding as the Propafenone Hydrochloride Price is obtained through a variety of data sources. The Propafenone Hydrochloride Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Abbott Brand of Propafenone Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Abbott Brand of Propafenone Hydrochloride, including repackagers and relabelers. The FDA regulates Abbott Brand of Propafenone Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Abbott Brand of 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 Abbott Brand of Propafenone Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Abbott Brand of Propafenone Hydrochloride supplier is an individual or a company that provides Abbott Brand of Propafenone Hydrochloride active pharmaceutical ingredient (API) or Abbott Brand of Propafenone Hydrochloride finished formulations upon request. The Abbott Brand of Propafenone Hydrochloride suppliers may include Abbott Brand of Propafenone Hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Abbott Brand of Propafenone Hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Abbott Brand of Propafenone Hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Abbott Brand of Propafenone Hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of Abbott Brand of Propafenone Hydrochloride DMFs exist exist since differing nations have different regulations, such as Abbott Brand of Propafenone Hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Abbott Brand of Propafenone Hydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. Abbott Brand of Propafenone Hydrochloride USDMF includes data on Abbott Brand of Propafenone Hydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Abbott Brand of Propafenone Hydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Abbott Brand of Propafenone Hydrochloride suppliers with USDMF on PharmaCompass.
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 Abbott Brand of Propafenone Hydrochloride Drug Master File in Japan (Abbott Brand of Propafenone Hydrochloride JDMF) empowers Abbott Brand of 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 Abbott Brand of Propafenone Hydrochloride JDMF during the approval evaluation for pharmaceutical products. At the time of Abbott Brand 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.
click here to find a list of Abbott Brand of Propafenone Hydrochloride suppliers with JDMF 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 Abbott Brand of Propafenone Hydrochloride Drug Master File in Korea (Abbott Brand of Propafenone Hydrochloride KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Abbott Brand of Propafenone Hydrochloride. The MFDS reviews the Abbott Brand of Propafenone Hydrochloride KDMF as part of the drug registration process and uses the information provided in the Abbott Brand of Propafenone Hydrochloride KDMF to evaluate the safety and efficacy of the drug.
After submitting a Abbott Brand of 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 Abbott Brand of Propafenone Hydrochloride API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Abbott Brand of Propafenone Hydrochloride suppliers with KDMF on PharmaCompass.
A Abbott Brand of Propafenone Hydrochloride CEP of the European Pharmacopoeia monograph is often referred to as a Abbott Brand of Propafenone Hydrochloride Certificate of Suitability (COS). The purpose of a Abbott Brand of Propafenone Hydrochloride CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Abbott Brand of Propafenone Hydrochloride EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Abbott Brand of Propafenone Hydrochloride to their clients by showing that a Abbott Brand of Propafenone Hydrochloride CEP has been issued for it. The manufacturer submits a Abbott Brand of Propafenone Hydrochloride CEP (COS) as part of the market authorization procedure, and it takes on the role of a Abbott Brand of Propafenone Hydrochloride CEP holder for the record. Additionally, the data presented in the Abbott Brand of Propafenone Hydrochloride CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Abbott Brand of Propafenone Hydrochloride DMF.
A Abbott Brand of Propafenone Hydrochloride CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Abbott Brand of Propafenone 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 Abbott Brand of Propafenone Hydrochloride suppliers with CEP (COS) on PharmaCompass.
A Abbott Brand of Propafenone Hydrochloride written confirmation (Abbott Brand of Propafenone Hydrochloride WC) is an official document issued by a regulatory agency to a Abbott Brand of Propafenone Hydrochloride manufacturer, verifying that the manufacturing facility of a Abbott Brand of Propafenone Hydrochloride active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Abbott Brand of Propafenone Hydrochloride APIs or Abbott Brand of Propafenone Hydrochloride finished pharmaceutical products to another nation, regulatory agencies frequently require a Abbott Brand of Propafenone Hydrochloride WC (written confirmation) as part of the regulatory process.
click here to find a list of Abbott Brand of Propafenone 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 Abbott Brand of Propafenone Hydrochloride as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Abbott Brand of 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 Abbott Brand of 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 Abbott Brand of Propafenone Hydrochloride and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Abbott Brand of Propafenone Hydrochloride NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Abbott Brand of Propafenone Hydrochloride suppliers with NDC on PharmaCompass.
Abbott Brand of 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 Abbott Brand 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 Abbott Brand of Propafenone Hydrochloride GMP manufacturer or Abbott Brand of Propafenone Hydrochloride GMP API supplier for your needs.
A Abbott Brand of Propafenone Hydrochloride CoA (Certificate of Analysis) is a formal document that attests to Abbott Brand of Propafenone Hydrochloride's compliance with Abbott Brand of Propafenone Hydrochloride specifications and serves as a tool for batch-level quality control.
Abbott Brand of Propafenone Hydrochloride CoA mostly includes findings from lab analyses of a specific batch. For each Abbott Brand of 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.
Abbott Brand of Propafenone Hydrochloride may be tested according to a variety of international standards, such as European Pharmacopoeia (Abbott Brand of Propafenone Hydrochloride EP), Abbott Brand of Propafenone Hydrochloride JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Abbott Brand of Propafenone Hydrochloride USP).
