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