gmp
gmp

Overview of Digoxin

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DSSTox_CID_2934
  • Synopsis

  • Chemistry

PharmaCompass
API SUPPLIERS
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US DMFs Filed

US DMFs Filed

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CEP/COS Certifications

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JDMFs Filed

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USA (Orange Book)

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Europe

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Canada

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Australia

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EXCIPIENTS
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ListLIST
  • FDA
  • EDQM
Applications: Capsugel’s soft gelatin capsules and technologies brings a range of formulation and commercial benefits to the pharmaceutical and dietary supplement markets.
Ingredient(s): Gelatin, Unspecified
More Info on Category: Soft Gelatin
Route of Administration (Grade): Oral; Ocular; Vaginal
Pharmacopoeia Reference: Not Available
Technical Specifications: Not Available
  • WHO-GMP
Applications: Pharmacel® 102 has good flow properties enabling high speed direct compression tableting. It is a ideal choice for direct compression & dry granulation formulations and it also has some lubrication properties for smooth tableting experience.
Dosage Form: Tablet
More Info on Category: Direct Compression
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- 310 g/l; Particle size- D10- 40 ?m, D50- 90 ?m, D90-180 ?m; Hausner ratio-1,42
  • 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
  • FDA
  • EDQM
Applications: Pharmasperse® 416 is a versatile drug delivery system (DDS) comprised of excipients such as mannitol. It is specifically engineered to manufacture orally dispersible powder (ODP) formulations.
Ingredient(s): Mannitol
Route of Administration (Grade): Oral
Pharmacopoeia Reference: Not Available
Technical Specifications: Not Available
  • WHO-GMP
Applications: Ready mix Film coating system for moisture sensitive APIs
Ingredient(s): Stearic Acid
Dosage Form: Capsule, Tablet
Route of Administration (Grade): Oral
Pharmacopoeia Reference: USP / EP / JP; Having US-DMF
Technical Specifications: Moisture barrier film coating system
  • 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
  • WHO-GMP
Applications: Primellose® croscarmellose sodium is an effective super-disintegrant ,suitable for a variety of tablet and capsule formulations. It is effective when used intragranular and/or extragranular in granular formulations.
Ingredient(s): Croscarmellose Sodium
More Info on Category: Disintegrants & Superdisintegrants
Route of Administration (Grade): Oral
Pharmacopoeia Reference: Conforms to USP-NF, Ph.Eur., JP
Technical Specifications: Not Available
  • WHO-GMP
Applications: SuperTab® 11SD offers the best compactability of all grades of lactose, and it is well suited to direct compression applications. Due to the low moisture content, it is used in the formulations containing moisture sensitive drugs.
Ingredient(s): Anhydrous Lactose
Dosage Form: Tablet
More Info on Category: Direct Compression
Route of Administration (Grade): Oral
Pharmacopoeia Reference: Conforms to Ph. Eur., Lactose monograph / USP-NF, JP Anhydrous lactose monograph
Technical Specifications: Density- Tapped density- 906 g/l, Bulk density- 722 g/l; Particle size- D10-15 ?m, D50- 170 ?m, D90- 340 ?m; Hausner ratio-1,25
  • 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
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  • TABLET;ORAL - 0.0625MG
  • TABLET;ORAL - 0.125MG
  • TABLET;ORAL - 0.1875MG
  • TABLET;ORAL - 0.25MG
  • ELIXIR;ORAL - 0.05MG/ML
  • INJECTABLE;INJECTION - 0.1MG/ML
  • INJECTABLE;INJECTION - 0.25MG/ML
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