AfricaRegulatory
African Pharmaceutical Regulatory Intelligence
APREMILAST
15 registrations across 3 African markets— 11 active
Markets with APREMILAST
Recent registrations
| Brand / Product | Market | Holder | Status | Expires |
|---|---|---|---|---|
| APREMILAST 20 mg GLENMARK | 🇿🇦South Africa | Glenmark Pharmaceuticals South Africa (Pty) Ltd | active | Feb 2028 |
| APREMILAST 30 mg GLENMARK | 🇿🇦South Africa | Glenmark Pharmaceuticals South Africa (Pty) Ltd | active | Feb 2028 |
| APTIKA 10 mg | 🇿🇦South Africa | Glenmark Pharmaceuticals South Africa (Pty) Ltd | active | Feb 2028 |
| APTIKA 20 mg | 🇿🇦South Africa | Glenmark Pharmaceuticals South Africa (Pty) Ltd | active | Feb 2028 |
| APTIKA 30 mg | 🇿🇦South Africa | Glenmark Pharmaceuticals South Africa (Pty) Ltd | active | Feb 2028 |
| APREMILAST 10 mg GLENMARK | 🇿🇦South Africa | Glenmark Pharmaceuticals South Africa (Pty) Ltd | active | Feb 2028 |
| APREZO STARTER PACK Film-Coated Tablet | 🇰🇪Kenya | Glenmark Pharmaceuticals Limited | active | Sept 2026 |
| OTEZLA 10 mg | 🇿🇦South Africa | Amgen South Africa (Pty)Ltd | suspended | Jul 2025 |
| OTEZLA Starter Pack | 🇿🇦South Africa | Amgen South Africa (Pty)Ltd | suspended | Jul 2025 |
| OTEZLA 20 mg | 🇿🇦South Africa | Amgen South Africa (Pty)Ltd | suspended | Jul 2025 |
| OTEZLA 30 mg | 🇿🇦South Africa | Amgen South Africa (Pty)Ltd | suspended | Jul 2025 |
| APREMILAST Oral Solid
Ordinary Film-
Coated Tablets | 🇺🇬Uganda | GLENMARK PHARMACEUTICA LS LTD | active | — |
| APREMILAST Oral Solid Ordinary
Film-Coated Tablets | 🇺🇬Uganda | GLENMARK PHARMACEUTICA LS LTD | active | — |
| APREMILAST Oral Solid
Ordinary Film-
Coated Tablets | 🇺🇬Uganda | GLENMARK PHARMACEUTICA LS LTD | active | — |
| APREMILAST Oral Solid Ordinary
Film-Coated Tablets | 🇺🇬Uganda | GLENMARK PHARMACEUTICA LS LTD | active | — |
APREMILAST in Africa — Regulatory Overview
APREMILAST is registered across 3 African markets with 15 total product registrations on file. Data is sourced directly from official national drug regulatory authorities including South Africa, Uganda, Kenya. AfricaRegulatory refreshes this data daily from official government sources.
Of the 15 registrations, 11 (73%) 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.