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PharmaCompass offers a list of Potassium Chloride 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 Chloride manufacturer or Potassium Chloride supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Potassium Chloride manufacturer or Potassium Chloride supplier.
PharmaCompass also assists you with knowing the Potassium Chloride API Price utilized in the formulation of products. Potassium Chloride API Price is not always fixed or binding as the Potassium Chloride Price is obtained through a variety of data sources. The Potassium Chloride Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Klotrix manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Klotrix, including repackagers and relabelers. The FDA regulates Klotrix manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Klotrix 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 Klotrix manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Klotrix supplier is an individual or a company that provides Klotrix active pharmaceutical ingredient (API) or Klotrix finished formulations upon request. The Klotrix suppliers may include Klotrix API manufacturers, exporters, distributors and traders.
click here to find a list of Klotrix suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Klotrix DMF (Drug Master File) is a document detailing the whole manufacturing process of Klotrix active pharmaceutical ingredient (API) in detail. Different forms of Klotrix DMFs exist exist since differing nations have different regulations, such as Klotrix USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Klotrix DMF submitted to regulatory agencies in the US is known as a USDMF. Klotrix USDMF includes data on Klotrix's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Klotrix USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Klotrix 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 Klotrix Drug Master File in Japan (Klotrix JDMF) empowers Klotrix 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 Klotrix JDMF during the approval evaluation for pharmaceutical products. At the time of Klotrix 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 Klotrix suppliers with JDMF on PharmaCompass.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Klotrix Drug Master File in Korea (Klotrix KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Klotrix. The MFDS reviews the Klotrix KDMF as part of the drug registration process and uses the information provided in the Klotrix KDMF to evaluate the safety and efficacy of the drug.
After submitting a Klotrix KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Klotrix API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Klotrix suppliers with KDMF on PharmaCompass.
A Klotrix CEP of the European Pharmacopoeia monograph is often referred to as a Klotrix Certificate of Suitability (COS). The purpose of a Klotrix CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Klotrix EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Klotrix to their clients by showing that a Klotrix CEP has been issued for it. The manufacturer submits a Klotrix CEP (COS) as part of the market authorization procedure, and it takes on the role of a Klotrix CEP holder for the record. Additionally, the data presented in the Klotrix CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Klotrix DMF.
A Klotrix CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Klotrix 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 Klotrix suppliers with CEP (COS) on PharmaCompass.
A Klotrix written confirmation (Klotrix WC) is an official document issued by a regulatory agency to a Klotrix manufacturer, verifying that the manufacturing facility of a Klotrix active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Klotrix APIs or Klotrix finished pharmaceutical products to another nation, regulatory agencies frequently require a Klotrix WC (written confirmation) as part of the regulatory process.
click here to find a list of Klotrix 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 Klotrix as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Klotrix 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 Klotrix 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 Klotrix and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Klotrix NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Klotrix suppliers with NDC on PharmaCompass.
Klotrix 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 Klotrix 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 Klotrix GMP manufacturer or Klotrix GMP API supplier for your needs.
A Klotrix CoA (Certificate of Analysis) is a formal document that attests to Klotrix's compliance with Klotrix specifications and serves as a tool for batch-level quality control.
Klotrix CoA mostly includes findings from lab analyses of a specific batch. For each Klotrix 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.
Klotrix may be tested according to a variety of international standards, such as European Pharmacopoeia (Klotrix EP), Klotrix JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Klotrix USP).