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