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List of Drug Master Files (JDMF) for Phenytoin Active Pharmaceutical Ingredient (API) submitted to the Review Authority in Japan (PMDA). Original Data : PMDA Database

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01 Katwijk Chemie bv (1)

02 Shizuoka Caffeine Industry Co., Ltd. (1)

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01 Japanese Pharmacopoeia phenytoin (production only) (2)

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01 Japan (1)

02 Netherlands (1)

URL Supplier Web Content
218MF10527
Snijderstraat 6,2222 BA, Katwijk, Z...
2006-05-18
2006-05-18
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URL Supplier Web Content
217MF10615
129 Suidocho, Aoi Ward, Shizuoka Ci...
2008-05-29
2005-09-14
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Looking for 57-41-0 / Phenytoin API manufacturers, exporters & distributors?

Phenytoin manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Phenytoin 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 manufacturer or Phenytoin supplier for your needs.

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Phenytoin manufacturer or Phenytoin supplier.

PharmaCompass also assists you with knowing the Phenytoin API Price utilized in the formulation of products. Phenytoin API Price is not always fixed or binding as the Phenytoin Price is obtained through a variety of data sources. The Phenytoin Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

Phenytoin

Synonyms

5,5-diphenylhydantoin, 57-41-0, Diphenylhydantoin, Dilantin, 5,5-diphenylimidazolidine-2,4-dione, Phenytoine

Cas Number

57-41-0

Unique Ingredient Identifier (UNII)

6158TKW0C5

About Phenytoin

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.

Phenytoin Manufacturers

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

Phenytoin Suppliers

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

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

Phenytoin JDMF

The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.

The Phenytoin Drug Master File in Japan (Phenytoin JDMF) empowers Phenytoin API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).

PMDA reviews the Phenytoin JDMF during the approval evaluation for pharmaceutical products. At the time of Phenytoin JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.

click here to find a list of Phenytoin suppliers with JDMF on PharmaCompass.

Phenytoin Manufacturers | Traders | Suppliers

Phenytoin Manufacturers, Traders, Suppliers 1
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We have 2 companies offering Phenytoin

Get in contact with the supplier of your choice:

  1. Katwijk Chemie
  2. Nippi
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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