Synopsis
0
JDMF
0
KDMF
0
VMF
0
Australia
DRUG PRODUCT COMPOSITIONS0
US Patents
0
US Exclusivities
0
Health Canada Patents
0
Data Compilation #PharmaFlow
0
Stock Recap #PipelineProspector
0
Weekly News Recap #Phispers
API SUPPLIERS
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
USDMF
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]CEP/COS
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results] EU WC
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]NDC API
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Listed Suppliers
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDF Dossiers
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDA Orange Book
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Europe
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Canada
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]DRUG PRODUCT COMPOSITIONS
DOSAGE - INJECTABLE;INJECTION - 50MG/ML
USFDA APPLICATION NUMBER - 84307
DOSAGE - CAPSULE;ORAL - 100MG EXTENDED
USFDA APPLICATION NUMBER - 84349
DOSAGE - CAPSULE;ORAL - 30MG EXTENDED
USFDA APPLICATION NUMBER - 84349
Related Excipient Companies
Rochem International Inc
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]SPI Pharma
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Faran Shimi Pharmaceutical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Boai NKY Pharmaceuticals Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Gangwal Healthcare
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Nanjing Well Pharmaceutical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Pfanstiehl
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]ACG Worldwide
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Actylis
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Aeon Procare
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Anhui Sunhere Pharmaceutical Excipients Co.,Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Ashland
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Corel Pharma Chem
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]DFE Pharma
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Finar
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Gangwal Chemicals
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Ideal Cures Pvt Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Ingredion Pharma Solutions
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Kerry
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Kima Chemical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Lonza Capsugel
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Microlex e.U
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Novo Excipients
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Pharmatrans-Sanaq
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Pluviaendo
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Prachin Chemical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Qianhao Chemical (Hebei) Co., Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Qualicaps
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Roquette
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Seppic
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Shanghai Shenmei Pharmaceutical Technology Co., Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Shijiazhuang Huaxu Pharmaceutical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Sigachi Industries
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Silverline Chemicals
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]The Dow Chemical Company
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Fillers, Diluents & Binders
Coating Systems & Additives
Direct Compression
Thickeners and Stabilizers
Controlled & Modified Release
Granulation
Taste Masking
Lubricants & Glidants
Chewable & Orodispersible Aids
Co-Processed Excipients
Solubilizers
Parenteral
Film Formers & Plasticizers
Disintegrants & Superdisintegrants
Topical
Empty Capsules
Rheology Modifiers
Emulsifying Agents
Coloring Agents
Vegetarian Capsules
API Stability Enhancers
Surfactant & Foaming Agents
Digital Content
NEWS #PharmaBuzz
Global Sales Information
US Medicaid Prescriptions
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Market Place
REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
35
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 Fenitron manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Fenitron, including repackagers and relabelers. The FDA regulates Fenitron manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Fenitron 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 Fenitron manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Fenitron supplier is an individual or a company that provides Fenitron active pharmaceutical ingredient (API) or Fenitron finished formulations upon request. The Fenitron suppliers may include Fenitron API manufacturers, exporters, distributors and traders.
click here to find a list of Fenitron suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Fenitron DMF (Drug Master File) is a document detailing the whole manufacturing process of Fenitron active pharmaceutical ingredient (API) in detail. Different forms of Fenitron DMFs exist exist since differing nations have different regulations, such as Fenitron USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Fenitron DMF submitted to regulatory agencies in the US is known as a USDMF. Fenitron USDMF includes data on Fenitron's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Fenitron USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Fenitron suppliers with USDMF on PharmaCompass.
A Fenitron CEP of the European Pharmacopoeia monograph is often referred to as a Fenitron Certificate of Suitability (COS). The purpose of a Fenitron CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Fenitron EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Fenitron to their clients by showing that a Fenitron CEP has been issued for it. The manufacturer submits a Fenitron CEP (COS) as part of the market authorization procedure, and it takes on the role of a Fenitron CEP holder for the record. Additionally, the data presented in the Fenitron CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Fenitron DMF.
A Fenitron CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Fenitron 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 Fenitron suppliers with CEP (COS) on PharmaCompass.
A Fenitron written confirmation (Fenitron WC) is an official document issued by a regulatory agency to a Fenitron manufacturer, verifying that the manufacturing facility of a Fenitron active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Fenitron APIs or Fenitron finished pharmaceutical products to another nation, regulatory agencies frequently require a Fenitron WC (written confirmation) as part of the regulatory process.
click here to find a list of Fenitron 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 Fenitron as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Fenitron 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 Fenitron 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 Fenitron and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Fenitron NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Fenitron suppliers with NDC on PharmaCompass.
Fenitron 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 Fenitron 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 Fenitron GMP manufacturer or Fenitron GMP API supplier for your needs.
A Fenitron CoA (Certificate of Analysis) is a formal document that attests to Fenitron's compliance with Fenitron specifications and serves as a tool for batch-level quality control.
Fenitron CoA mostly includes findings from lab analyses of a specific batch. For each Fenitron 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.
Fenitron may be tested according to a variety of international standards, such as European Pharmacopoeia (Fenitron EP), Fenitron JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Fenitron USP).
