# Omeprazole

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

Omeprazole is a proton pump inhibitor active substance from the benzimidazole class. It is acid- and light-sensitive, so packaging, storage and transport conditions are part of our documentation review.

Synonyms: Omeprazolum

## Technical data

| Property | Value |
|---|---|
| CAS | 73590-58-6 |
| Molecular formula | C17H19N3O3S |
| Molar mass | 345.42 g/mol |
| Pharmacopoeia / standards | Ph. Eur. 0942; USP |
| Grade | Ph. Eur. / USP, pharmaceutical grade; pellets on request |
| Appearance | White or almost white powder; shows polymorphism |
| Typical packaging | Light- and moisture-protected fibre drums with double PE liners |
| 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 gastro-resistant oral 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 17 of 30 valid CEPs for omeprazole (EDQM database, 15 Oct 2026; GFC count).

## Verification

- https://pubchem.ncbi.nlm.nih.gov/compound/4594

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