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