# Apixaban

Source: https://gfclinics.pl/ingredients/apixaban/
Last reviewed: 2026-10-17 · Green Future Clinics P.S.A.

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.

Synonyms: Apixabanum

## Technical data

| Property | Value |
|---|---|
| CAS | 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) |
| Category | API |
| Status | In evaluation |

## Documents provided

- 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

## 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.

## Verification

- https://pubchem.ncbi.nlm.nih.gov/compound/10182969

Quotes and documents: https://gfclinics.pl/contact/?product=apixaban