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