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REF. STANDARDS & IMPURITIES
ANALYTICAL
ABOUT THIS PAGE
11
PharmaCompass offers a list of Trimetazidine Hydrochloride API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, 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.
A Vastarel manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Vastarel, including repackagers and relabelers. The FDA regulates Vastarel manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Vastarel 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 Vastarel manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Vastarel supplier is an individual or a company that provides Vastarel active pharmaceutical ingredient (API) or Vastarel finished formulations upon request. The Vastarel suppliers may include Vastarel API manufacturers, exporters, distributors and traders.
click here to find a list of Vastarel suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Vastarel DMF (Drug Master File) is a document detailing the whole manufacturing process of Vastarel active pharmaceutical ingredient (API) in detail. Different forms of Vastarel DMFs exist exist since differing nations have different regulations, such as Vastarel USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Vastarel DMF submitted to regulatory agencies in the US is known as a USDMF. Vastarel USDMF includes data on Vastarel's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Vastarel USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Vastarel 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 Vastarel Drug Master File in Japan (Vastarel JDMF) empowers Vastarel 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 Vastarel JDMF during the approval evaluation for pharmaceutical products. At the time of Vastarel 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 Vastarel 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 Vastarel Drug Master File in Korea (Vastarel KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Vastarel. The MFDS reviews the Vastarel KDMF as part of the drug registration process and uses the information provided in the Vastarel KDMF to evaluate the safety and efficacy of the drug.
After submitting a Vastarel 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 Vastarel API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Vastarel suppliers with KDMF on PharmaCompass.
A Vastarel CEP of the European Pharmacopoeia monograph is often referred to as a Vastarel Certificate of Suitability (COS). The purpose of a Vastarel CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Vastarel EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Vastarel to their clients by showing that a Vastarel CEP has been issued for it. The manufacturer submits a Vastarel CEP (COS) as part of the market authorization procedure, and it takes on the role of a Vastarel CEP holder for the record. Additionally, the data presented in the Vastarel CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Vastarel DMF.
A Vastarel CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Vastarel 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 Vastarel suppliers with CEP (COS) on PharmaCompass.
A Vastarel written confirmation (Vastarel WC) is an official document issued by a regulatory agency to a Vastarel manufacturer, verifying that the manufacturing facility of a Vastarel active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Vastarel APIs or Vastarel finished pharmaceutical products to another nation, regulatory agencies frequently require a Vastarel WC (written confirmation) as part of the regulatory process.
click here to find a list of Vastarel 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 Vastarel as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Vastarel 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 Vastarel 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 Vastarel and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Vastarel NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Vastarel suppliers with NDC on PharmaCompass.
Vastarel 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 Vastarel GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Vastarel GMP manufacturer or Vastarel GMP API supplier for your needs.
A Vastarel CoA (Certificate of Analysis) is a formal document that attests to Vastarel's compliance with Vastarel specifications and serves as a tool for batch-level quality control.
Vastarel CoA mostly includes findings from lab analyses of a specific batch. For each Vastarel 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.
Vastarel may be tested according to a variety of international standards, such as European Pharmacopoeia (Vastarel EP), Vastarel JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Vastarel USP).
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