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ABOUT THIS PAGE
A Sodium Nitroprusside manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Sodium Nitroprusside, including repackagers and relabelers. The FDA regulates Sodium Nitroprusside manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Sodium Nitroprusside 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 Nitroprusside manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Sodium Nitroprusside supplier is an individual or a company that provides Sodium Nitroprusside active pharmaceutical ingredient (API) or Sodium Nitroprusside finished formulations upon request. The Sodium Nitroprusside suppliers may include Sodium Nitroprusside API manufacturers, exporters, distributors and traders.
click here to find a list of Sodium Nitroprusside suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Sodium Nitroprusside DMF (Drug Master File) is a document detailing the whole manufacturing process of Sodium Nitroprusside active pharmaceutical ingredient (API) in detail. Different forms of Sodium Nitroprusside DMFs exist exist since differing nations have different regulations, such as Sodium Nitroprusside USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Sodium Nitroprusside DMF submitted to regulatory agencies in the US is known as a USDMF. Sodium Nitroprusside USDMF includes data on Sodium Nitroprusside's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Sodium Nitroprusside USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Sodium Nitroprusside suppliers with USDMF on PharmaCompass.
A Sodium Nitroprusside CEP of the European Pharmacopoeia monograph is often referred to as a Sodium Nitroprusside Certificate of Suitability (COS). The purpose of a Sodium Nitroprusside CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Sodium Nitroprusside EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Sodium Nitroprusside to their clients by showing that a Sodium Nitroprusside CEP has been issued for it. The manufacturer submits a Sodium Nitroprusside CEP (COS) as part of the market authorization procedure, and it takes on the role of a Sodium Nitroprusside CEP holder for the record. Additionally, the data presented in the Sodium Nitroprusside CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Sodium Nitroprusside DMF.
A Sodium Nitroprusside CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Sodium Nitroprusside 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 Sodium Nitroprusside suppliers with CEP (COS) on PharmaCompass.
A Sodium Nitroprusside written confirmation (Sodium Nitroprusside WC) is an official document issued by a regulatory agency to a Sodium Nitroprusside manufacturer, verifying that the manufacturing facility of a Sodium Nitroprusside active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Sodium Nitroprusside APIs or Sodium Nitroprusside finished pharmaceutical products to another nation, regulatory agencies frequently require a Sodium Nitroprusside WC (written confirmation) as part of the regulatory process.
click here to find a list of Sodium Nitroprusside 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 Nitroprusside as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Sodium Nitroprusside 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 Nitroprusside 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 Nitroprusside and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Sodium Nitroprusside NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Sodium Nitroprusside suppliers with NDC on PharmaCompass.
Sodium Nitroprusside 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 Nitroprusside 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 Nitroprusside GMP manufacturer or Sodium Nitroprusside GMP API supplier for your needs.
A Sodium Nitroprusside CoA (Certificate of Analysis) is a formal document that attests to Sodium Nitroprusside's compliance with Sodium Nitroprusside specifications and serves as a tool for batch-level quality control.
Sodium Nitroprusside CoA mostly includes findings from lab analyses of a specific batch. For each Sodium Nitroprusside 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 Nitroprusside may be tested according to a variety of international standards, such as European Pharmacopoeia (Sodium Nitroprusside EP), Sodium Nitroprusside JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Sodium Nitroprusside USP).
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