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Overview of Fexofenadine Hydrochloride

Client Email Product
Fexofenadine
  • Synopsis

  • Chemistry

PharmaCompass
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US DMFs Filed

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JDMFs Filed

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INTERMEDIATES
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USA (Orange Book)

USA (Orange Book)

Europe

Europe

Canada

Canada

Australia

Australia

South Africa

South Africa

Uploaded Dossiers

Uploaded Dossiers

GLOBAL SALES (USD Million)

U.S. Medicaid

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EXCIPIENTS
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USFDA Orange Book Patents

USFDA Exclusivities

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REFERENCE STANDARD

EDQM

USP

JP

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SERVICES
  • FDA
  • EDQM
Applications: It offers an enteric-release profile to the upper gastro-intestinal tract that meets the disintegration requirements for delayed-release capsules for the European, US and Japanese Phamacopoeia.
Ingredient(s): HPMC AS
Dosage Form: Capsule
Route of Administration (Grade): Oral
Pharmacopoeia Reference: Complies with relevant European, Japanese and US Pharmacopeia monographs
Technical Specifications: Water content – less than 6%; Size #0
  • WHO-GMP
Applications: Direct compression for modified release dosage forms
Dosage Form: Capsule, Tablet
Route of Administration (Grade): Solid Oral
Pharmacopoeia Reference: Not Available
Technical Specifications: Microcrystalline Cellulose, Ethylcellulose , Hydroxypropyl methyl cellulose K4M, Hydroxypropyl Cellulose, Colloidal Silicon Dioxide, Maize Starch, Magnesium Stearate and Talc
  • FDA
Applications: Film Forming Agent, Wet/Dry Granulation- Binder,Thickening & Suspension Agent, Non-Gelatin Capsule Manufacturing & Enteric Film Coating Systems
Dosage Form: Capsule, Tablet
Route of Administration (Grade): Not Available
Pharmacopoeia Reference: USP, EP, and JP
Technical Specifications: Not Available
  • FDA
  • EDQM
Applications: Controlled Release, Direct Compression,Wet Granulation,Tablet Coating, Liquid Solutions and Suspensions
Dosage Form: Tablet, Capsule
Route of Administration (Grade): Not Available
Pharmacopoeia Reference: Not Available
Technical Specifications: Not Available
  • FDA
Applications: Sustained Release Tablet Matrix
Dosage Form: Capsule, Tablet
Route of Administration (Grade): Not Available
Pharmacopoeia Reference: USP, EP, and JP
Technical Specifications: Not Available
  • FDA
Applications: Immediate Release
Ingredient(s): Starch
Dosage Form: Tablet
Route of Administration (Grade): Not Available
Pharmacopoeia Reference: Customized per requirements
Technical Specifications: Not Available
  • FDA
  • EDQM
Applications: Moisture barrier, Multi particulates, Dry powder layering, Granulation, Hot melt extrusion, Taste Masking, Controlled / Modified Release
Ingredient(s): EthylCellulose
Route of Administration (Grade): Not Available
Pharmacopoeia Reference: Not Available
Technical Specifications: Not Available
  • FDA
Applications: Immediate Release
Dosage Form: Tablet
Route of Administration (Grade): Not Available
Pharmacopoeia Reference: Customized per requirements
Technical Specifications: Not Available
  • FDA
Applications: Immediate Release
Dosage Form: Tablet
Route of Administration (Grade): Not Available
Pharmacopoeia Reference: Customized per requirements
Technical Specifications: Not Available
  • FDA
Applications: Immediate Release
Dosage Form: Tablet
Route of Administration (Grade): Not Available
Pharmacopoeia Reference: Customized per requirements
Technical Specifications: Not Available
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  • SUSPENSION;ORAL - 30MG/5ML
  • TABLET, EXTENDED RELEASE;ORAL - 60MG;120MG
  • TABLET;ORAL - 180MG
  • TABLET;ORAL - 30MG
  • TABLET;ORAL - 60MG
  • TABLET, EXTENDED RELEASE;ORAL - 180MG;240MG
  • TABLET, ORALLY DISINTEGRATING;ORAL - 30MG
  • SUSPENSION;ORAL - 30MG/5ML
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