gmp
gmp

Overview of Digoxin

Client Email Product
DSSTox_CID_2934
  • Synopsis

  • Chemistry

PharmaCompass
API SUPPLIERS
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US DMFs Filed

US DMFs Filed

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USA (Orange Book)

USA (Orange Book)

Europe

Europe

Canada

Canada

Australia

Australia

South Africa

South Africa

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Uploaded Dossiers

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EXCIPIENTS
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REFERENCE STANDARD

EDQM

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SERVICES

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  • 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
  • FDA
  • EDQM
Applications: Mannogem (Mannitol Powder) dissolves rapidly and can increase the rate of tablet disintegration, subsequent drug dissolution and drug release.
Ingredient(s): Mannitol
Dosage Form: Granule / Pellet, Tablet
Route of Administration (Grade): Oral
Pharmacopoeia Reference: Not Available
Technical Specifications: Not Available
  • 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: Blend homogeneity even for low dose and micronized API’s, No need of other auxillary excipients
Route of Administration (Grade): Solid Oral
Pharmacopoeia Reference: USP-NF
Technical Specifications: Microcrystalline Cellulose and Colloidal Silicon Dioxide
  • WHO-GMP
Applications: Direct Compression, Dry Granulation
Ingredient(s): Lactose Monohydrate
Route of Administration (Grade): Solid Oral
Pharmacopoeia Reference: IP, BP, USP-NF
Technical Specifications: Not Available
  • WHO-GMP
Applications: Direct Compression, Dry Granulation
Ingredient(s): Anhydrous Lactose
Route of Administration (Grade): Solid Oral
Pharmacopoeia Reference: Not Available
Technical Specifications: Maize starch and Lactose anhydrous
  • 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.
    Applications: AceCel is suitable for majority of the directly compressible actives, combines good flow and high compressibility.
    Dosage Form: Tablet
    Route of Administration (Grade): Oral
    Pharmacopoeia Reference: Not Available
    Technical Specifications: Not Available
      Applications: HiCel acts as a strong & dry binder. It facilitates low tablet friability & promotes rapid tablet disintegration.
      Dosage Form: Tablet
      Route of Administration (Grade): Oral
      Pharmacopoeia Reference: Not Available
      Technical Specifications: Not Available
        Applications: Tablets made from these granules are typically easily disintegrated using conventional super disintegrates even when hard tablets are compressed.
        Dosage Form: Tablet
        More Info on Category: Direct Compression, Granulation
        Route of Administration (Grade): Oral
        Pharmacopoeia Reference: Monograph- USP/NF, JP/JPE
        Technical Specifications: Not Available
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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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