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