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