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Overview of Methotrexate

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Methotrexate
  • Synopsis

  • Chemistry

PharmaCompass
API SUPPLIERS
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US DMFs Filed

US DMFs Filed

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CEP/COS Certifications

JDMFs Filed

JDMFs Filed

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USA (Orange Book)

Europe

Europe

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Australia

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GLOBAL SALES (USD Million)

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EXCIPIENTS
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USFDA Orange Book Patents

USFDA Exclusivities

MEDIA

Blog

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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
  • 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: 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 for pH sensitive APIs
Dosage Form: Capsule, Tablet
Route of Administration (Grade): Solid Oral
Pharmacopoeia Reference: Not Available
Technical Specifications: Microcrystalline Cellulose, Light Magnesium Oxide, Sodium Starch Glycolate, Pregelatinized Starch, Maize Starch
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  • INJECTABLE;INJECTION - EQ 1GM BASE/40ML (EQ 25MG BASE/ML)
  • INJECTABLE;INJECTION - EQ 500MG BASE/20ML (EQ 25MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
  • INJECTABLE;INJECTION - EQ 50MG BASE/2ML (EQ 25MG BASE/ML)
  • SOLUTION;SUBCUTANEOUS - 10MG/0.4ML (10MG/0.4ML)
  • SOLUTION;SUBCUTANEOUS - 12.5MG/0.4ML (12.5MG/0.4ML)
  • SOLUTION;SUBCUTANEOUS - 15MG/0.4ML (15MG/0.4ML)
  • SOLUTION;SUBCUTANEOUS - 17.5MG/0.4ML (17.5MG/0.4ML)
  • SOLUTION;SUBCUTANEOUS - 20MG/0.4ML (20MG/0.4ML)
  • SOLUTION;SUBCUTANEOUS - 22.5MG/0.4ML (22.5MG/0.4ML)
  • SOLUTION;SUBCUTANEOUS - 25MG/0.4ML (25MG/0.4ML)
  • SOLUTION;SUBCUTANEOUS - 7.5MG/0.4ML (7.5MG/0.4ML)
  • SOLUTION;SUBCUTANEOUS - 10MG/0.20ML (10MG/0.20ML)
  • SOLUTION;SUBCUTANEOUS - 12.5MG/0.25ML (12.5MG/0.25ML)
  • SOLUTION;SUBCUTANEOUS - 15MG/0.30ML (15MG/0.30ML)
  • SOLUTION;SUBCUTANEOUS - 17.5MG/0.35ML (17.5MG/0.35ML)
  • SOLUTION;SUBCUTANEOUS - 20MG/0.4ML (20MG/0.4ML)
  • SOLUTION;SUBCUTANEOUS - 22.5MG/0.45ML (22.5MG/0.45ML)
  • SOLUTION;SUBCUTANEOUS - 25MG/0.5ML (25MG/0.5ML)
  • SOLUTION;SUBCUTANEOUS - 27.5MG/0.55ML (27.5MG/0.55ML)
  • SOLUTION;SUBCUTANEOUS - 30MG/0.6ML (30MG/0.6ML)
  • SOLUTION;SUBCUTANEOUS - 7.5MG/0.15ML (7.5MG/0.15ML)
  • SOLUTION;ORAL - EQ 2MG BASE/ML
  • TABLET;ORAL - EQ 2.5MG BASE
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