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  • INJECTABLE;INJECTION - 50MG/ML
  • CAPSULE;ORAL - 100MG EXTENDED
  • CAPSULE;ORAL - 30MG EXTENDED

Looking for 630-93-3 / Phenytoin Sodium API manufacturers, exporters & distributors?

Phenytoin Sodium manufacturers, exporters & distributors 1

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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.

API | Excipient name

Phenytoin Sodium

Synonyms

630-93-3, 5,5-diphenylhydantoin sodium salt, Dilantin sodium, Diphenylhydantoin sodium, Diphantoine, Tacosal

Cas Number

630-93-3

Unique Ingredient Identifier (UNII)

4182431BJH

About Phenytoin Sodium

An anticonvulsant that is used to treat a wide variety of seizures. It is also an anti-arrhythmic and a muscle relaxant. The mechanism of therapeutic action is not clear, although several cellular actions have been described including effects on ion channels, active transport, and general membrane stabilization. The mechanism of its muscle relaxant effect appears to involve a reduction in the sensitivity of muscle spindles to stretch. Phenytoin has been proposed for several other therapeutic uses, but its use has been limited by its many adverse effects and interactions with other drugs.

Phenylhydantoin Manufacturers

A Phenylhydantoin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Phenylhydantoin, including repackagers and relabelers. The FDA regulates Phenylhydantoin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Phenylhydantoin 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 Phenylhydantoin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Phenylhydantoin Suppliers

A Phenylhydantoin supplier is an individual or a company that provides Phenylhydantoin active pharmaceutical ingredient (API) or Phenylhydantoin finished formulations upon request. The Phenylhydantoin suppliers may include Phenylhydantoin API manufacturers, exporters, distributors and traders.

click here to find a list of Phenylhydantoin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

Phenylhydantoin USDMF

A Phenylhydantoin DMF (Drug Master File) is a document detailing the whole manufacturing process of Phenylhydantoin active pharmaceutical ingredient (API) in detail. Different forms of Phenylhydantoin DMFs exist exist since differing nations have different regulations, such as Phenylhydantoin USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A Phenylhydantoin DMF submitted to regulatory agencies in the US is known as a USDMF. Phenylhydantoin USDMF includes data on Phenylhydantoin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Phenylhydantoin USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of Phenylhydantoin suppliers with USDMF on PharmaCompass.

Phenylhydantoin CEP

A Phenylhydantoin CEP of the European Pharmacopoeia monograph is often referred to as a Phenylhydantoin Certificate of Suitability (COS). The purpose of a Phenylhydantoin CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Phenylhydantoin EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Phenylhydantoin to their clients by showing that a Phenylhydantoin CEP has been issued for it. The manufacturer submits a Phenylhydantoin CEP (COS) as part of the market authorization procedure, and it takes on the role of a Phenylhydantoin CEP holder for the record. Additionally, the data presented in the Phenylhydantoin CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Phenylhydantoin DMF.

A Phenylhydantoin CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Phenylhydantoin 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 Phenylhydantoin suppliers with CEP (COS) on PharmaCompass.

Phenylhydantoin WC

A Phenylhydantoin written confirmation (Phenylhydantoin WC) is an official document issued by a regulatory agency to a Phenylhydantoin manufacturer, verifying that the manufacturing facility of a Phenylhydantoin active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Phenylhydantoin APIs or Phenylhydantoin finished pharmaceutical products to another nation, regulatory agencies frequently require a Phenylhydantoin WC (written confirmation) as part of the regulatory process.

click here to find a list of Phenylhydantoin suppliers with Written Confirmation (WC) on PharmaCompass.

Phenylhydantoin NDC

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 Phenylhydantoin as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Phenylhydantoin API and other APIs are published in this directory by the FDA.

Unfinished drugs

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 Phenylhydantoin 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.

Compounded drug products

The NDC directory also contains data on finished compounded human drug products that contain Phenylhydantoin and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Phenylhydantoin NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of Phenylhydantoin suppliers with NDC on PharmaCompass.

Phenylhydantoin GMP

Phenylhydantoin 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 Phenylhydantoin 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 Phenylhydantoin GMP manufacturer or Phenylhydantoin GMP API supplier for your needs.

Phenylhydantoin CoA

A Phenylhydantoin CoA (Certificate of Analysis) is a formal document that attests to Phenylhydantoin's compliance with Phenylhydantoin specifications and serves as a tool for batch-level quality control.

Phenylhydantoin CoA mostly includes findings from lab analyses of a specific batch. For each Phenylhydantoin 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.

Phenylhydantoin may be tested according to a variety of international standards, such as European Pharmacopoeia (Phenylhydantoin EP), Phenylhydantoin JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Phenylhydantoin USP).

Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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