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