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