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PharmaCompass offers a list of Thiopental Sodium 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 Thiopental Sodium manufacturer or Thiopental Sodium supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Thiopental Sodium manufacturer or Thiopental Sodium supplier.
PharmaCompass also assists you with knowing the Thiopental Sodium API Price utilized in the formulation of products. Thiopental Sodium API Price is not always fixed or binding as the Thiopental Sodium Price is obtained through a variety of data sources. The Thiopental Sodium Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A 5-Ethyl-5-(1-methylbutyl)-2-thiobarbituric acid monosodium manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of 5-Ethyl-5-(1-methylbutyl)-2-thiobarbituric acid monosodium, including repackagers and relabelers. The FDA regulates 5-Ethyl-5-(1-methylbutyl)-2-thiobarbituric acid monosodium manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. 5-Ethyl-5-(1-methylbutyl)-2-thiobarbituric acid monosodium 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 5-Ethyl-5-(1-methylbutyl)-2-thiobarbituric acid monosodium manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A 5-Ethyl-5-(1-methylbutyl)-2-thiobarbituric acid monosodium supplier is an individual or a company that provides 5-Ethyl-5-(1-methylbutyl)-2-thiobarbituric acid monosodium active pharmaceutical ingredient (API) or 5-Ethyl-5-(1-methylbutyl)-2-thiobarbituric acid monosodium finished formulations upon request. The 5-Ethyl-5-(1-methylbutyl)-2-thiobarbituric acid monosodium suppliers may include 5-Ethyl-5-(1-methylbutyl)-2-thiobarbituric acid monosodium API manufacturers, exporters, distributors and traders.
click here to find a list of 5-Ethyl-5-(1-methylbutyl)-2-thiobarbituric acid monosodium suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A 5-Ethyl-5-(1-methylbutyl)-2-thiobarbituric acid monosodium DMF (Drug Master File) is a document detailing the whole manufacturing process of 5-Ethyl-5-(1-methylbutyl)-2-thiobarbituric acid monosodium active pharmaceutical ingredient (API) in detail. Different forms of 5-Ethyl-5-(1-methylbutyl)-2-thiobarbituric acid monosodium DMFs exist exist since differing nations have different regulations, such as 5-Ethyl-5-(1-methylbutyl)-2-thiobarbituric acid monosodium USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A 5-Ethyl-5-(1-methylbutyl)-2-thiobarbituric acid monosodium DMF submitted to regulatory agencies in the US is known as a USDMF. 5-Ethyl-5-(1-methylbutyl)-2-thiobarbituric acid monosodium USDMF includes data on 5-Ethyl-5-(1-methylbutyl)-2-thiobarbituric acid monosodium's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The 5-Ethyl-5-(1-methylbutyl)-2-thiobarbituric acid monosodium USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of 5-Ethyl-5-(1-methylbutyl)-2-thiobarbituric acid monosodium 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 5-Ethyl-5-(1-methylbutyl)-2-thiobarbituric acid monosodium Drug Master File in Japan (5-Ethyl-5-(1-methylbutyl)-2-thiobarbituric acid monosodium JDMF) empowers 5-Ethyl-5-(1-methylbutyl)-2-thiobarbituric acid monosodium 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 5-Ethyl-5-(1-methylbutyl)-2-thiobarbituric acid monosodium JDMF during the approval evaluation for pharmaceutical products. At the time of 5-Ethyl-5-(1-methylbutyl)-2-thiobarbituric acid monosodium 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 5-Ethyl-5-(1-methylbutyl)-2-thiobarbituric acid monosodium suppliers with JDMF on PharmaCompass.
A 5-Ethyl-5-(1-methylbutyl)-2-thiobarbituric acid monosodium CEP of the European Pharmacopoeia monograph is often referred to as a 5-Ethyl-5-(1-methylbutyl)-2-thiobarbituric acid monosodium Certificate of Suitability (COS). The purpose of a 5-Ethyl-5-(1-methylbutyl)-2-thiobarbituric acid monosodium CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of 5-Ethyl-5-(1-methylbutyl)-2-thiobarbituric acid monosodium EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of 5-Ethyl-5-(1-methylbutyl)-2-thiobarbituric acid monosodium to their clients by showing that a 5-Ethyl-5-(1-methylbutyl)-2-thiobarbituric acid monosodium CEP has been issued for it. The manufacturer submits a 5-Ethyl-5-(1-methylbutyl)-2-thiobarbituric acid monosodium CEP (COS) as part of the market authorization procedure, and it takes on the role of a 5-Ethyl-5-(1-methylbutyl)-2-thiobarbituric acid monosodium CEP holder for the record. Additionally, the data presented in the 5-Ethyl-5-(1-methylbutyl)-2-thiobarbituric acid monosodium CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the 5-Ethyl-5-(1-methylbutyl)-2-thiobarbituric acid monosodium DMF.
A 5-Ethyl-5-(1-methylbutyl)-2-thiobarbituric acid monosodium CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. 5-Ethyl-5-(1-methylbutyl)-2-thiobarbituric acid monosodium 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 5-Ethyl-5-(1-methylbutyl)-2-thiobarbituric acid monosodium suppliers with CEP (COS) 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 5-Ethyl-5-(1-methylbutyl)-2-thiobarbituric acid monosodium as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for 5-Ethyl-5-(1-methylbutyl)-2-thiobarbituric acid monosodium 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 5-Ethyl-5-(1-methylbutyl)-2-thiobarbituric acid monosodium 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 5-Ethyl-5-(1-methylbutyl)-2-thiobarbituric acid monosodium and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a 5-Ethyl-5-(1-methylbutyl)-2-thiobarbituric acid monosodium NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of 5-Ethyl-5-(1-methylbutyl)-2-thiobarbituric acid monosodium suppliers with NDC on PharmaCompass.
5-Ethyl-5-(1-methylbutyl)-2-thiobarbituric acid monosodium 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 5-Ethyl-5-(1-methylbutyl)-2-thiobarbituric acid monosodium 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 5-Ethyl-5-(1-methylbutyl)-2-thiobarbituric acid monosodium GMP manufacturer or 5-Ethyl-5-(1-methylbutyl)-2-thiobarbituric acid monosodium GMP API supplier for your needs.
A 5-Ethyl-5-(1-methylbutyl)-2-thiobarbituric acid monosodium CoA (Certificate of Analysis) is a formal document that attests to 5-Ethyl-5-(1-methylbutyl)-2-thiobarbituric acid monosodium's compliance with 5-Ethyl-5-(1-methylbutyl)-2-thiobarbituric acid monosodium specifications and serves as a tool for batch-level quality control.
5-Ethyl-5-(1-methylbutyl)-2-thiobarbituric acid monosodium CoA mostly includes findings from lab analyses of a specific batch. For each 5-Ethyl-5-(1-methylbutyl)-2-thiobarbituric acid monosodium 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.
5-Ethyl-5-(1-methylbutyl)-2-thiobarbituric acid monosodium may be tested according to a variety of international standards, such as European Pharmacopoeia (5-Ethyl-5-(1-methylbutyl)-2-thiobarbituric acid monosodium EP), 5-Ethyl-5-(1-methylbutyl)-2-thiobarbituric acid monosodium JP (Japanese Pharmacopeia) and the US Pharmacopoeia (5-Ethyl-5-(1-methylbutyl)-2-thiobarbituric acid monosodium USP).
