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    List of Drug Master Files (DMF) of Phenytoin Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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    01 KUNSHAN ORIENTAL PHARMACEUTICAL CO LTD (1)

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    KUNSHAN ORIENTAL PHARMACEUTICAL CO ...

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      PHENYTOIN

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      20434
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      2007-03-25
      N/A
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      RECORDATI INDUSTRIA CHIMICA E FARMA...

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      PHENYTOIN

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      23226
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      2009-10-29
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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 USDMF

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

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

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

      Phenytoin Manufacturers | Traders | Suppliers

      Phenytoin Manufacturers, Traders, Suppliers 1
      84

      We have 2 companies offering Phenytoin

      Get in contact with the supplier of your choice:

      1. KUNSHAN ORIENTAL PHARMACEUTICAL CO LTD
      2. Recordati
      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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