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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 1-(2,6-dimethylphenoxy)-2-amino-propane hydrochloride; manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of 1-(2,6-dimethylphenoxy)-2-amino-propane hydrochloride;, including repackagers and relabelers. The FDA regulates 1-(2,6-dimethylphenoxy)-2-amino-propane hydrochloride; manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. 1-(2,6-dimethylphenoxy)-2-amino-propane 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 1-(2,6-dimethylphenoxy)-2-amino-propane hydrochloride; manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A 1-(2,6-dimethylphenoxy)-2-amino-propane hydrochloride; supplier is an individual or a company that provides 1-(2,6-dimethylphenoxy)-2-amino-propane hydrochloride; active pharmaceutical ingredient (API) or 1-(2,6-dimethylphenoxy)-2-amino-propane hydrochloride; finished formulations upon request. The 1-(2,6-dimethylphenoxy)-2-amino-propane hydrochloride; suppliers may include 1-(2,6-dimethylphenoxy)-2-amino-propane hydrochloride; API manufacturers, exporters, distributors and traders.
click here to find a list of 1-(2,6-dimethylphenoxy)-2-amino-propane hydrochloride; suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A 1-(2,6-dimethylphenoxy)-2-amino-propane hydrochloride; DMF (Drug Master File) is a document detailing the whole manufacturing process of 1-(2,6-dimethylphenoxy)-2-amino-propane hydrochloride; active pharmaceutical ingredient (API) in detail. Different forms of 1-(2,6-dimethylphenoxy)-2-amino-propane hydrochloride; DMFs exist exist since differing nations have different regulations, such as 1-(2,6-dimethylphenoxy)-2-amino-propane hydrochloride; USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A 1-(2,6-dimethylphenoxy)-2-amino-propane hydrochloride; DMF submitted to regulatory agencies in the US is known as a USDMF. 1-(2,6-dimethylphenoxy)-2-amino-propane hydrochloride; USDMF includes data on 1-(2,6-dimethylphenoxy)-2-amino-propane hydrochloride;'s chemical properties, information on the facilities and procedures used, and details about packaging and storage. The 1-(2,6-dimethylphenoxy)-2-amino-propane 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 1-(2,6-dimethylphenoxy)-2-amino-propane hydrochloride; Drug Master File in Japan (1-(2,6-dimethylphenoxy)-2-amino-propane hydrochloride; JDMF) empowers 1-(2,6-dimethylphenoxy)-2-amino-propane 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 1-(2,6-dimethylphenoxy)-2-amino-propane hydrochloride; JDMF during the approval evaluation for pharmaceutical products. At the time of 1-(2,6-dimethylphenoxy)-2-amino-propane 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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A 1-(2,6-dimethylphenoxy)-2-amino-propane hydrochloride; CEP of the European Pharmacopoeia monograph is often referred to as a 1-(2,6-dimethylphenoxy)-2-amino-propane hydrochloride; Certificate of Suitability (COS). The purpose of a 1-(2,6-dimethylphenoxy)-2-amino-propane hydrochloride; CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of 1-(2,6-dimethylphenoxy)-2-amino-propane hydrochloride; EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of 1-(2,6-dimethylphenoxy)-2-amino-propane hydrochloride; to their clients by showing that a 1-(2,6-dimethylphenoxy)-2-amino-propane hydrochloride; CEP has been issued for it. The manufacturer submits a 1-(2,6-dimethylphenoxy)-2-amino-propane hydrochloride; CEP (COS) as part of the market authorization procedure, and it takes on the role of a 1-(2,6-dimethylphenoxy)-2-amino-propane hydrochloride; CEP holder for the record. Additionally, the data presented in the 1-(2,6-dimethylphenoxy)-2-amino-propane hydrochloride; CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the 1-(2,6-dimethylphenoxy)-2-amino-propane hydrochloride; DMF.
A 1-(2,6-dimethylphenoxy)-2-amino-propane hydrochloride; CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. 1-(2,6-dimethylphenoxy)-2-amino-propane 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 1-(2,6-dimethylphenoxy)-2-amino-propane hydrochloride; written confirmation (1-(2,6-dimethylphenoxy)-2-amino-propane hydrochloride; WC) is an official document issued by a regulatory agency to a 1-(2,6-dimethylphenoxy)-2-amino-propane hydrochloride; manufacturer, verifying that the manufacturing facility of a 1-(2,6-dimethylphenoxy)-2-amino-propane hydrochloride; active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting 1-(2,6-dimethylphenoxy)-2-amino-propane hydrochloride; APIs or 1-(2,6-dimethylphenoxy)-2-amino-propane hydrochloride; finished pharmaceutical products to another nation, regulatory agencies frequently require a 1-(2,6-dimethylphenoxy)-2-amino-propane hydrochloride; WC (written confirmation) as part of the regulatory process.
click here to find a list of 1-(2,6-dimethylphenoxy)-2-amino-propane 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 1-(2,6-dimethylphenoxy)-2-amino-propane hydrochloride; as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for 1-(2,6-dimethylphenoxy)-2-amino-propane 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 1-(2,6-dimethylphenoxy)-2-amino-propane 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 1-(2,6-dimethylphenoxy)-2-amino-propane hydrochloride; and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a 1-(2,6-dimethylphenoxy)-2-amino-propane hydrochloride; NDC to their finished compounded human drug products, they may choose to do so.
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1-(2,6-dimethylphenoxy)-2-amino-propane 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 1-(2,6-dimethylphenoxy)-2-amino-propane 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 1-(2,6-dimethylphenoxy)-2-amino-propane hydrochloride; GMP manufacturer or 1-(2,6-dimethylphenoxy)-2-amino-propane hydrochloride; GMP API supplier for your needs.
A 1-(2,6-dimethylphenoxy)-2-amino-propane hydrochloride; CoA (Certificate of Analysis) is a formal document that attests to 1-(2,6-dimethylphenoxy)-2-amino-propane hydrochloride;'s compliance with 1-(2,6-dimethylphenoxy)-2-amino-propane hydrochloride; specifications and serves as a tool for batch-level quality control.
1-(2,6-dimethylphenoxy)-2-amino-propane hydrochloride; CoA mostly includes findings from lab analyses of a specific batch. For each 1-(2,6-dimethylphenoxy)-2-amino-propane 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.
1-(2,6-dimethylphenoxy)-2-amino-propane hydrochloride; may be tested according to a variety of international standards, such as European Pharmacopoeia (1-(2,6-dimethylphenoxy)-2-amino-propane hydrochloride; EP), 1-(2,6-dimethylphenoxy)-2-amino-propane hydrochloride; JP (Japanese Pharmacopeia) and the US Pharmacopoeia (1-(2,6-dimethylphenoxy)-2-amino-propane hydrochloride; USP).