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