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