# Ibuprofen

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

Ibuprofen is a propionic-acid non-steroidal anti-inflammatory drug (NSAID) active substance and a widely used generic API. Green Future Clinics offers Ph. Eur. grade ibuprofen from Indian manufacturers that hold a valid CEP.

Synonyms: Ibuprofenum; (RS)-2-[4-(2-methylpropyl)phenyl]propanoic acid

## Technical data

| Property | Value |
|---|---|
| CAS | 15687-27-1 |
| EC | 239-784-6 |
| Molecular formula | C13H18O2 |
| Molar mass | 206.28 g/mol |
| Pharmacopoeia / standards | Ph. Eur. 0721; USP |
| Grade | Ph. Eur. / USP, pharmaceutical grade |
| Appearance | White or almost white crystalline powder or colourless crystals |
| Typical packaging | 25 kg fibre drums with double polyethylene liners (pack sizes per manufacturer) |
| Category | API |
| Status | Core range |

## 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 oral and topical medicinal products made by authorised manufacturers. Particle-size grades for direct compression on request.

## Regulatory notes

Active substance under Directive 2001/83/EC. Imports from India require a Written Confirmation (Art. 46b). Supplied only to authorised manufacturers and wholesalers.

## Market context

Indian manufacturers hold 8 of 13 valid CEPs for ibuprofen (EDQM database, 15 Oct 2026; GFC count).

## Verification

- https://pubchem.ncbi.nlm.nih.gov/compound/3672
- https://www.edqm.eu/en/certification-of-suitability

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