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PharmaCompass offers a list of Trimetazidine 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 Trimetazidine manufacturer or Trimetazidine supplier for your needs.
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PharmaCompass also assists you with knowing the Trimetazidine API Price utilized in the formulation of products. Trimetazidine API Price is not always fixed or binding as the Trimetazidine Price is obtained through a variety of data sources. The Trimetazidine Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A 1-(2,3,4-Trimethoxybenzyl)piperazine dihydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of 1-(2,3,4-Trimethoxybenzyl)piperazine dihydrochloride, including repackagers and relabelers. The FDA regulates 1-(2,3,4-Trimethoxybenzyl)piperazine dihydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. 1-(2,3,4-Trimethoxybenzyl)piperazine dihydrochloride API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A 1-(2,3,4-Trimethoxybenzyl)piperazine dihydrochloride supplier is an individual or a company that provides 1-(2,3,4-Trimethoxybenzyl)piperazine dihydrochloride active pharmaceutical ingredient (API) or 1-(2,3,4-Trimethoxybenzyl)piperazine dihydrochloride finished formulations upon request. The 1-(2,3,4-Trimethoxybenzyl)piperazine dihydrochloride suppliers may include 1-(2,3,4-Trimethoxybenzyl)piperazine dihydrochloride API manufacturers, exporters, distributors and traders.
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A 1-(2,3,4-Trimethoxybenzyl)piperazine dihydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of 1-(2,3,4-Trimethoxybenzyl)piperazine dihydrochloride active pharmaceutical ingredient (API) in detail. Different forms of 1-(2,3,4-Trimethoxybenzyl)piperazine dihydrochloride DMFs exist exist since differing nations have different regulations, such as 1-(2,3,4-Trimethoxybenzyl)piperazine dihydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A 1-(2,3,4-Trimethoxybenzyl)piperazine dihydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. 1-(2,3,4-Trimethoxybenzyl)piperazine dihydrochloride USDMF includes data on 1-(2,3,4-Trimethoxybenzyl)piperazine dihydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The 1-(2,3,4-Trimethoxybenzyl)piperazine dihydrochloride 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-(2,3,4-Trimethoxybenzyl)piperazine dihydrochloride Drug Master File in Japan (1-(2,3,4-Trimethoxybenzyl)piperazine dihydrochloride JDMF) empowers 1-(2,3,4-Trimethoxybenzyl)piperazine dihydrochloride 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-(2,3,4-Trimethoxybenzyl)piperazine dihydrochloride JDMF during the approval evaluation for pharmaceutical products. At the time of 1-(2,3,4-Trimethoxybenzyl)piperazine dihydrochloride 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 1-(2,3,4-Trimethoxybenzyl)piperazine dihydrochloride Drug Master File in Korea (1-(2,3,4-Trimethoxybenzyl)piperazine dihydrochloride KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of 1-(2,3,4-Trimethoxybenzyl)piperazine dihydrochloride. The MFDS reviews the 1-(2,3,4-Trimethoxybenzyl)piperazine dihydrochloride KDMF as part of the drug registration process and uses the information provided in the 1-(2,3,4-Trimethoxybenzyl)piperazine dihydrochloride KDMF to evaluate the safety and efficacy of the drug.
After submitting a 1-(2,3,4-Trimethoxybenzyl)piperazine dihydrochloride 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 1-(2,3,4-Trimethoxybenzyl)piperazine dihydrochloride API can apply through the Korea Drug Master File (KDMF).
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A 1-(2,3,4-Trimethoxybenzyl)piperazine dihydrochloride CEP of the European Pharmacopoeia monograph is often referred to as a 1-(2,3,4-Trimethoxybenzyl)piperazine dihydrochloride Certificate of Suitability (COS). The purpose of a 1-(2,3,4-Trimethoxybenzyl)piperazine dihydrochloride CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of 1-(2,3,4-Trimethoxybenzyl)piperazine dihydrochloride EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of 1-(2,3,4-Trimethoxybenzyl)piperazine dihydrochloride to their clients by showing that a 1-(2,3,4-Trimethoxybenzyl)piperazine dihydrochloride CEP has been issued for it. The manufacturer submits a 1-(2,3,4-Trimethoxybenzyl)piperazine dihydrochloride CEP (COS) as part of the market authorization procedure, and it takes on the role of a 1-(2,3,4-Trimethoxybenzyl)piperazine dihydrochloride CEP holder for the record. Additionally, the data presented in the 1-(2,3,4-Trimethoxybenzyl)piperazine dihydrochloride CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the 1-(2,3,4-Trimethoxybenzyl)piperazine dihydrochloride DMF.
A 1-(2,3,4-Trimethoxybenzyl)piperazine dihydrochloride CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. 1-(2,3,4-Trimethoxybenzyl)piperazine dihydrochloride 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-(2,3,4-Trimethoxybenzyl)piperazine dihydrochloride written confirmation (1-(2,3,4-Trimethoxybenzyl)piperazine dihydrochloride WC) is an official document issued by a regulatory agency to a 1-(2,3,4-Trimethoxybenzyl)piperazine dihydrochloride manufacturer, verifying that the manufacturing facility of a 1-(2,3,4-Trimethoxybenzyl)piperazine dihydrochloride active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting 1-(2,3,4-Trimethoxybenzyl)piperazine dihydrochloride APIs or 1-(2,3,4-Trimethoxybenzyl)piperazine dihydrochloride finished pharmaceutical products to another nation, regulatory agencies frequently require a 1-(2,3,4-Trimethoxybenzyl)piperazine dihydrochloride 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 1-(2,3,4-Trimethoxybenzyl)piperazine dihydrochloride as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for 1-(2,3,4-Trimethoxybenzyl)piperazine dihydrochloride 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-(2,3,4-Trimethoxybenzyl)piperazine dihydrochloride 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-(2,3,4-Trimethoxybenzyl)piperazine dihydrochloride and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a 1-(2,3,4-Trimethoxybenzyl)piperazine dihydrochloride NDC to their finished compounded human drug products, they may choose to do so.
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1-(2,3,4-Trimethoxybenzyl)piperazine dihydrochloride 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-(2,3,4-Trimethoxybenzyl)piperazine dihydrochloride 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-(2,3,4-Trimethoxybenzyl)piperazine dihydrochloride GMP manufacturer or 1-(2,3,4-Trimethoxybenzyl)piperazine dihydrochloride GMP API supplier for your needs.
A 1-(2,3,4-Trimethoxybenzyl)piperazine dihydrochloride CoA (Certificate of Analysis) is a formal document that attests to 1-(2,3,4-Trimethoxybenzyl)piperazine dihydrochloride's compliance with 1-(2,3,4-Trimethoxybenzyl)piperazine dihydrochloride specifications and serves as a tool for batch-level quality control.
1-(2,3,4-Trimethoxybenzyl)piperazine dihydrochloride CoA mostly includes findings from lab analyses of a specific batch. For each 1-(2,3,4-Trimethoxybenzyl)piperazine dihydrochloride 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-(2,3,4-Trimethoxybenzyl)piperazine dihydrochloride may be tested according to a variety of international standards, such as European Pharmacopoeia (1-(2,3,4-Trimethoxybenzyl)piperazine dihydrochloride EP), 1-(2,3,4-Trimethoxybenzyl)piperazine dihydrochloride JP (Japanese Pharmacopeia) and the US Pharmacopoeia (1-(2,3,4-Trimethoxybenzyl)piperazine dihydrochloride USP).
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