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