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GDUFA

DMF Review : Complete

Rev. Date : 2015-09-28

Pay. Date : 2015-09-15

DMF Number : 5384

Submission : 1984-06-06

Status : Active

Type : II

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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.

Dilantin Manufacturers

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

Dilantin Suppliers

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

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

Dilantin USDMF

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

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

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

Dilantin Manufacturers | Traders | Suppliers

Dilantin Manufacturers, Traders, Suppliers 1
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.