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PharmaCompass offers a list of Potassium 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 manufacturer or Potassium supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Potassium manufacturer or Potassium supplier.
PharmaCompass also assists you with knowing the Potassium API Price utilized in the formulation of products. Potassium API Price is not always fixed or binding as the Potassium Price is obtained through a variety of data sources. The Potassium Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Kalium manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Kalium, including repackagers and relabelers. The FDA regulates Kalium manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Kalium 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 Kalium manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Kalium supplier is an individual or a company that provides Kalium active pharmaceutical ingredient (API) or Kalium finished formulations upon request. The Kalium suppliers may include Kalium API manufacturers, exporters, distributors and traders.
click here to find a list of Kalium suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Kalium DMF (Drug Master File) is a document detailing the whole manufacturing process of Kalium active pharmaceutical ingredient (API) in detail. Different forms of Kalium DMFs exist exist since differing nations have different regulations, such as Kalium USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Kalium DMF submitted to regulatory agencies in the US is known as a USDMF. Kalium USDMF includes data on Kalium's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Kalium USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Kalium 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 Kalium Drug Master File in Japan (Kalium JDMF) empowers Kalium 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 Kalium JDMF during the approval evaluation for pharmaceutical products. At the time of Kalium 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 Kalium suppliers with JDMF on PharmaCompass.
A Kalium written confirmation (Kalium WC) is an official document issued by a regulatory agency to a Kalium manufacturer, verifying that the manufacturing facility of a Kalium active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Kalium APIs or Kalium finished pharmaceutical products to another nation, regulatory agencies frequently require a Kalium WC (written confirmation) as part of the regulatory process.
click here to find a list of Kalium suppliers with Written Confirmation (WC) on PharmaCompass.
Kalium 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 Kalium 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 Kalium GMP manufacturer or Kalium GMP API supplier for your needs.
A Kalium CoA (Certificate of Analysis) is a formal document that attests to Kalium's compliance with Kalium specifications and serves as a tool for batch-level quality control.
Kalium CoA mostly includes findings from lab analyses of a specific batch. For each Kalium 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.
Kalium may be tested according to a variety of international standards, such as European Pharmacopoeia (Kalium EP), Kalium JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Kalium USP).
