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