APIs & intermediatesIn evaluation

Apixaban

Apixabanum

CAS503612-47-3FormulaC25H25N5O4

Apixaban is a direct factor Xa inhibitor active substance. Technical data are shared with licensed manufacturers only, and buyers should confirm patent and supplementary protection certificate status in each market before commercial use.

Technical data

CAS number
503612-47-3
Molecular formula
C25H25N5O4
Molar mass
459.50 g/mol
Grade
Manufacturer specification aligned with ICH Q6A; micronised grades on request
Appearance
White to pale yellow powder
Typical packaging
Sealed containers with double PE liners (pack size per manufacturer)

Documents we provide

  • CEP or ASMF (applicant’s part) with letter of access
  • EU GMP certificate or inspection record (EudraGMDP)
  • Written Confirmation (CDSCO)
  • Specification and batch CoA
  • Nitrosamine risk assessment
  • Elemental impurities (ICH Q3D) and residual solvents (ICH Q3C) statements
  • TSE/BSE statement

Typical package. The final list depends on the manufacturer and your specification.

Applications

Active substance for generic development and, where patent and SPC status allow, commercial oral medicinal products.

Regulatory notes

Active substance of a prescription-only medicine under Directive 2001/83/EC. Information is intended for licensed manufacturers; no promotion to the public.

Quick answers

What is the CAS number of Apixaban?

The CAS number of Apixaban is 503612-47-3. Molecular formula: C25H25N5O4, molar mass 459.5 g/mol.

Which documents come with Apixaban from Green Future Clinics?

The typical package includes: CEP or ASMF (applicant’s part) with letter of access; EU GMP certificate or inspection record (EudraGMDP); Written Confirmation (CDSCO); Specification and batch CoA. The final list depends on the manufacturer and on your specification.

Which grade of Apixaban is available?

Manufacturer specification aligned with ICH Q6A; micronised grades on request.

Verification

Identifiers checked against public databases on :

Need Apixaban?

Send grade, volume and the documents you need. We reply with availability and documentation status.

Or write to hello@gfclinics.pl