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Overview of Digoxin

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DSSTox_CID_2934
  • Synopsis

  • Chemistry

PharmaCompass
API SUPPLIERS
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API Suppliers

US DMFs Filed

US DMFs Filed

CEP/COS Certifications

CEP/COS Certifications

JDMFs Filed

JDMFs Filed

Other Certificates

Other Certificates

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Other Suppliers

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USA (Orange Book)

USA (Orange Book)

Europe

Europe

Canada

Canada

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Australia

South Africa

South Africa

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Uploaded Dossiers

GLOBAL SALES (USD Million)

U.S. Medicaid

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Dossiers Market Place

EXCIPIENTS
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USFDA Exclusivities

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MEDIA

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REFERENCE STANDARD

EDQM

USP

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SERVICES

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  • FDA
  • EDQM
Applications: Advantol® 300 is a directly compressible pharmaceutical excipient used to create soft chew or soft melt oral dosage forms. It is a robust system that enables rapid product development.
Ingredient(s): Mannitol
Route of Administration (Grade): Oral
Pharmacopoeia Reference: Not Available
Technical Specifications: Not Available
  • FDA
Applications: Mannitol is mainly used as a bulking agent in tableting. It is also used as taste masking agent in ODT formulations.
Ingredient(s): Mannitol
Dosage Form: Capsule, Tablet
Route of Administration (Grade): Oral
Pharmacopoeia Reference: Not Available
Technical Specifications: Not Available
  • 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, EP. US DMF Type IV filed.
Technical Specifications: Not Available
  • WHO-GMP
Applications: Direct Compression, Dry granulation
Route of Administration (Grade): Oral
Pharmacopoeia Reference: Not Available
Technical Specifications: Maize starch and Microcrystalline Cellulose
  • FDA
  • EDQM
Applications: Compressol® SM, co-processed polyol, is a directly compressible pharmaceutical excipient comprised of mannitol and sorbitol. It provides superior compactibility of sorbitol, while retaining lower hygroscopicity & a lower disintegration time.
Ingredient(s): Mannitol
Route of Administration (Grade): Oral
Pharmacopoeia Reference: Not Available
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: 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: Direct Compression, Dry Granulation
Dosage Form: Capsule, Tablet
Route of Administration (Grade): Oral
Pharmacopoeia Reference: Not Available
Technical Specifications: For small dose API and large dose API with good compressibility.
  • 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