# Montelukast sodium

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

Montelukast sodium is a leukotriene receptor antagonist active substance. It is under evaluation with Indian manufacturers that hold EU documentation; enquiries help us prioritise.

Synonyms: Montelukastum natricum

## Technical data

| Property | Value |
|---|---|
| CAS | 151767-02-1 |
| Molecular formula | C35H35ClNNaO3S |
| Molar mass | 608.17 g/mol |
| Pharmacopoeia / standards | Ph. Eur.; USP |
| Grade | Ph. Eur. / USP, pharmaceutical grade |
| Appearance | Hygroscopic, white to off-white powder |
| Typical packaging | Sealed, light-protected containers (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 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.

## Verification

- https://pubchem.ncbi.nlm.nih.gov/compound/23663996

Quotes and documents: https://gfclinics.pl/contact/?product=montelukast-sodium