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Overview of Ezetimibe

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Ezetimibe
  • Synopsis

  • Chemistry

PharmaCompass
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US DMFs Filed

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JDMFs Filed

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USA (Orange Book)

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EXCIPIENTS
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REFERENCE STANDARD

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SERVICES
  • WHO-GMP
Applications: Pharmatose® 200M is a highly consistent monohydrate lactose which delivers good compaction properties.This lactose type is typically used in tablets, capsules and extrusion spheronisation.
Ingredient(s): Lactose Monohydrate
Dosage Form: Capsule, Tablet
Route of Administration (Grade): Oral
Pharmacopoeia Reference: Conforms to USP-NF, Ph.Eur., JP lactose monohydrate monograph
Technical Specifications: Density- Tapped density- 857 g/l, Bulk density- 589 g/l; Particle size- D10- 5 ?m, D50- 40 ?m, D90- 120 ?m; Hausner ratio- 1,46
  • WHO-GMP
Applications: Pharmacel® 101 is a strong binder for wet & dry granulation formulations as it ensures uniform granulation and drying processes. It also provides excellent compaction and disintegration properties.
Dosage Form: Tablet
More Info on Category: Fillers, Diluents & Binders
Route of Administration (Grade): Oral
Pharmacopoeia Reference: Conforms to USP-NF, Ph.Eur., JP, IP
Technical Specifications: Density- Tapped density- 440 g/l, Bulk density- 280 g/l; Particle size- D10- 25 ?m, D50- 60 ?m, D90- 20 ?m; Hausner ratio-1,57
  • WHO-GMP
Applications: Direct Compression, Dry granulation
Route of Administration (Grade): Solid Oral
Pharmacopoeia Reference: Not Available
Technical Specifications: Maize starch and Microcrystalline Cellulose
  • WHO-GMP
Applications: Orally Disintegrating Tablets/Sachets, Dispersible Tablets, Sachets, Chewable Tablets, Sublingual Tablets
Ingredient(s): Crospovidone
Route of Administration (Grade): Oral
Pharmacopoeia Reference: Conforms to Japanese Pharmaceutical Excipients. All components meet USP-NF, JP, and EP. US DMF Type IV filed.
Technical Specifications: Not Available
  • WHO-GMP
Applications: SuperTab® 11SD is a highly consistent, spray-dried lactose enabling efficient tableting by offering free flow properties. It also offers excellent compaction properties & content uniformity.
Dosage Form: Tablet
More Info on Category: Fillers, Diluents & Binders
Route of Administration (Grade): Oral
Pharmacopoeia Reference: Conforms to USP-NF, Ph.Eur., JP lactose monohydrate monograph
Technical Specifications: Density- Tapped density- 716 g/l, Bulk density- 599 g/l; Particle size- D10-50 ?m, D50- 120 ?m, D90- 220 ?m; Hausner ratio-1,2
  • WHO-GMP
Applications: Direct Compression, Dry Granulation
Dosage Form: Capsule, Tablet
Route of Administration (Grade): Solid Oral
Pharmacopoeia Reference: Not Available
Technical Specifications: For small dose API and large dose API with good compressibility.
  • FDA
Applications: Direct Compression
Dosage Form: Capsule, Tablet
More Info on Category: Fillers, Diluents & Binders
Route of Administration (Grade): Not Available
Pharmacopoeia Reference: USP/NF, EP, and JP
Technical Specifications: Not Available
  • FDA
Applications: Direct Compression
Dosage Form: Tablet
More Info on Category: Fillers, Diluents & Binders
Route of Administration (Grade): Not Available
Pharmacopoeia Reference: USP/NF, EP, and JP
Technical Specifications: Not Available
  • WHO-GMP
Applications: Direct compression for moisture sensitive APIs
Dosage Form: Capsule, Tablet
Route of Administration (Grade): Solid Oral
Pharmacopoeia Reference: Not Available
Technical Specifications: Microcrystalline Cellulose, Colloidal Silicon Dioxide, Povidone K30 and Crospovidone
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  • TABLET;ORAL - EQ 10MG BASE;10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
  • TABLET;ORAL - EQ 20MG BASE;10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
  • TABLET;ORAL - EQ 40MG BASE;10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
  • TABLET;ORAL - EQ 80MG BASE;10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
  • TABLET;ORAL - 180MG;10MG
  • TABLET;ORAL - 10MG
  • TABLET;ORAL - 10MG;10MG
  • TABLET;ORAL - 10MG;20MG
  • TABLET;ORAL - 10MG;40MG
  • TABLET;ORAL - 10MG;80MG
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