AfricaRegulatory
African Pharmaceutical Regulatory Intelligence
MONTELUKAST SODIUM
140 registrations across 10 African markets— 124 active
Markets with MONTELUKAST SODIUM
🇺🇬Uganda
80 registrations
80 active
🇹🇿Tanzania
15 registrations
15 active
🇲🇼Malawi
13 registrations
0 active
🇰🇪Kenya
10 registrations
10 active
🇿🇼Zimbabwe
9 registrations
9 active
🇨🇮Côte d'Ivoire
3 registrations
0 active
🇷🇼Rwanda
3 registrations
3 active
🇿🇲Zambia
3 registrations
3 active
🇲🇬Madagascar
2 registrations
2 active
🇸🇳Senegal
2 registrations
2 active
Recent registrations
| Brand / Product | Market | Holder | Status | Expires |
|---|---|---|---|---|
| ALUKON® 4 Granules | 🇰🇪Kenya | Dafra Pharma GmbH | active | Jun 2031 |
| ALUKON® 10 Film-Coated Tablet | 🇰🇪Kenya | Dafra Pharma GmbH | active | Jun 2031 |
| ALUKON® 5 Chewable Tablet | 🇰🇪Kenya | Dafra Pharma GmbH | active | Jun 2031 |
| BREATH EZY 4 Chewable tablet | 🇷🇼Rwanda | MSN LABORATORIES PRIVATE LIMITED | active | Mar 2031 |
| BREATHEZY CW 5 Chewable Tablets | 🇷🇼Rwanda | MSN Laboratories Private Ltd. | active | Mar 2031 |
| M-kast 10 Tablet Uncoated | 🇿🇲Zambia | Aurobindo Pharma Limited | active | Oct 2030 |
| MONAST 10 TABLET; ORAL | 🇿🇼Zimbabwe | HETERO LABS LTD | active | Feb 2030 |
| BREATHEZY CW 5 TABLET; ORAL | 🇿🇼Zimbabwe | MSN LABORATORIES LTD | active | Sept 2029 |
| BREATHEZY TABLET; ORAL | 🇿🇼Zimbabwe | MSN LABORATORIES LTD | active | Sept 2029 |
| MONAST 10 Tablets | 🇷🇼Rwanda | M/s. Hetero Labs Limited | active | Aug 2029 |
| Monokast Tablets 5mg Film-Coated Tablet | 🇰🇪Kenya | Global Napi Pharmaceuticals | active | Jul 2028 |
| Monokast Tablets 10mg Film-Coated Tablet | 🇰🇪Kenya | Global Napi Pharmaceuticals | active | May 2028 |
| ASTHATORIO TABLET; ORAL | 🇿🇼Zimbabwe | TORRENT EXPORTS LTD | active | Dec 2027 |
| MONTEMAC 10 TABLET, COATED; ORAL | 🇿🇼Zimbabwe | MACLEODS PHARMACEUTICALS LIMITED | active | Dec 2027 |
| ASTHATOR 5 TABLET; ORAL | 🇿🇼Zimbabwe | TORRENT EXPORTS LTD | active | Dec 2027 |
| MONTERA 5 TABLET, COATED; ORAL | 🇿🇼Zimbabwe | COSPHARM INVESTMENTS PVT LIMITED | active | Dec 2027 |
| MONTERA 10 TABLET, COATED; ORAL | 🇿🇼Zimbabwe | COSPHARM INVESTMENTS PVT LIMITED | active | Dec 2027 |
| MONTERA 4 TABLET; ORAL | 🇿🇼Zimbabwe | COSPHARM INVESTMENTS PVT LIMITED | active | Dec 2027 |
| VITAGET 5MG Tablet | 🇰🇪Kenya | Eastleigh Pharmaceuticals Co. Ltd | active | Nov 2027 |
| VITAGET 10 Tablet | 🇰🇪Kenya | Eastleigh Pharmaceuticals Co. Ltd | active | Nov 2027 |
| VITAGET 4 Tablet | 🇰🇪Kenya | Eastleigh Pharmaceuticals Co. Ltd | active | Nov 2027 |
| Glenmont IR 10 Tablets Film coated tablet | 🇿🇲Zambia | Glenmark Pharmaceuticals Ltd | active | Feb 2027 |
| Montec 10 mg Tablet | 🇰🇪Kenya | Pharmatec Pakistan (Pvt) Ltd | active | Jan 2027 |
| Montec 5 mg Tablet | 🇰🇪Kenya | Pharmatec Pakistan (Pvt) Ltd | active | Jan 2027 |
| Montemac Tablets Tablet Chewable | 🇿🇲Zambia | Macleods Pharmaceuticals Limited | active | Oct 2026 |
| SINGULAIR 4MG COMPRIME A CROQUER BOITE DE 28 | 🇨🇮Côte d'Ivoire | LABORATOIRE ORGANON | expired | Jan 2026 |
| SINGULAIR 10MG COMPRIME A CROQUER BOITE DE 28 | 🇨🇮Côte d'Ivoire | LABORATOIRE ORGANON | expired | Jan 2026 |
| DENK_AIR_10 10MG TABLET TABLET | 🇲🇼Malawi | — | expired | Mar 2025 |
| DENK_AIR_JUNIOR_4 4MG TABLET TABLET | 🇲🇼Malawi | — | expired | Mar 2025 |
| DENK_AIR_JUNIOR_5 5MG TABLET TABLET | 🇲🇼Malawi | — | expired | Mar 2025 |
| MONTENAC-10 10MG TABLETS TABLETS | 🇲🇼Malawi | — | expired | Mar 2024 |
| BREATHEZY_CW_5 5MG CHEWABLE TABLET CHEWABLE TABLET | 🇲🇼Malawi | — | expired | Jun 2021 |
| BREATHEZY_10 10MG TABLET TABLET | 🇲🇼Malawi | — | expired | Jun 2021 |
| BREATHEZY_4 4MG CHEWABLE TABLET CHEWABLE TABLET | 🇲🇼Malawi | — | expired | Jun 2021 |
| SINGULAIR 5MG COMPRIME A CROQUER BOITE DE 28 | 🇨🇮Côte d'Ivoire | LABORATOIRE ORGANON | expired | Jan 2021 |
| MONAST_10 10MG TABLET TABLET | 🇲🇼Malawi | — | expired | Jun 2020 |
| ROMILAST~5 5MG CHEWABLE TABLETS CHEWABLE TABLETS | 🇲🇼Malawi | — | expired | Jun 2016 |
| MORAL_10 10MG TABLET TABLET | 🇲🇼Malawi | — | expired | Jun 2016 |
| MORAL_5 5MG CHEWABLE TABLET CHEWABLE TABLET | 🇲🇼Malawi | — | expired | Jun 2016 |
| MORAL_4 4MG CHEWABLE TABLET CHEWABLE TABLET | 🇲🇼Malawi | — | expired | Jun 2016 |
| ROMILAST-4 4MG CHEWABLE TABLETS CHEWABLE TABLETS | 🇲🇼Malawi | — | expired | Jun 2015 |
| MONTELUKAST
SODIUM ORAL SOLID
ORDINARY TABLETS | 🇺🇬Uganda | HETERO LABS LTD | active | — |
| MONTELUKAST
SODIUM ORAL SOLID
ORDINARY FILM-
COATED
TABLETS | 🇺🇬Uganda | UNICHEM LABORATORIES LTD | active | — |
| MONTELUKAST
SODIUM ORAL SOLID
ORDINARY FILM-
COATED TABLETS | 🇺🇬Uganda | MACLEODS PHARMACEUTICA LS LTD | active | — |
| MONTELUKAST
SODIUM ORAL SOLID
ORDINARY
CHEWABLE TABLETS | 🇺🇬Uganda | UNITED PHARMACEUTICA L MANUFACTURIN G CO. LTD | active | — |
| MONTELUKAST
SODIUM ORAL SOLID
ORDINARY FILM-
COATED TABLETS | 🇺🇬Uganda | MACLEODS PHARMACEUTICA LS LTD | active | — |
| MONTEMAC 10 CP PELL BTE(1 X 10 ; 3 X 10) MACLEODS comprimé pelliculé, boite 1 | 🇲🇬Madagascar | MACLEODS PHARMACEUTICALS | active | — |
| MONTELUKAST
SODIUM ORAL SOLID
ORDINARY FILM-
COATED TABLETS | 🇺🇬Uganda | GETZ PHARMA PVT LIMITED | active | — |
| MONTELUKAST
SODIUM ORAL SOLID
ORDINARY
CHEWABLE COATED
TABLETS | 🇺🇬Uganda | GETZ PHARMA PVT LIMITED | active | — |
| MONTELUKAST
SODIUM ORAL SOLID
ORDINARY
CHEWABLE TABLETS | 🇺🇬Uganda | HOVID BHD | active | — |
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MONTELUKAST SODIUM in Africa — Regulatory Overview
MONTELUKAST SODIUM is registered across 10 African markets with 140 total product registrations on file. Data is sourced directly from official national drug regulatory authorities including Uganda, Tanzania, Malawi, Kenya and 6 more. AfricaRegulatory refreshes this data daily from official government sources.
Of the 140 registrations, 124 (89%) are currently active. Regulatory affairs teams use AfricaRegulatory to track registration expiry dates, identify market incumbents, and monitor approval status across African markets without manual monitoring of each national regulator.