# Levetiracetam

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

Levetiracetam is an antiepileptic active substance, a pyrrolidone derivative supplied as the single (S)-enantiomer. Among our core APIs it has the highest share of valid CEPs held by Indian manufacturers.

Synonyms: Levetiracetamum; (2S)-2-(2-oxopyrrolidin-1-yl)butanamide

## Technical data

| Property | Value |
|---|---|
| CAS | 102767-28-2 |
| Molecular formula | C8H14N2O2 |
| Molar mass | 170.21 g/mol |
| Pharmacopoeia / standards | Ph. Eur. 2535; USP |
| Grade | Ph. Eur. / USP, pharmaceutical grade |
| Appearance | White or almost white powder |
| 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
- Enantiomeric purity data
- Elemental impurities (ICH Q3D) and residual solvents (ICH Q3C) statements
- TSE/BSE statement

## Applications

Active substance for oral and parenteral medicinal products made by authorised manufacturers.

## 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 26 of 37 valid CEPs for levetiracetam (EDQM database, 15 Oct 2026; GFC count).

## Verification

- https://pubchem.ncbi.nlm.nih.gov/compound/5284583

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