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