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