AfricaRegulatory
African Pharmaceutical Regulatory Intelligence
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Zolpidem Tartrate in South Africa
15 products registered with SAHPRA — 12 active
| Brand / Product | Reg. No. | Holder | Status | Expires |
|---|---|---|---|---|
| ZOLPIDEM XR 12,5 ADCO | 57/2.2/0188 | Adcock Ingram Limited | active | 21 Jan 2030 |
| ZILSUN MR | 54/2.2/0324 | Ranbaxy Pharmaceutical (Pty) Ltd | active | 3 Oct 2028 |
| ZOLPIDEM MR SUN | 54/2.2/0325.324 | Ranbaxy Pharmaceutical (Pty) Ltd | active | 3 Oct 2028 |
| ZOLNOREM 12,5 mg | 54/2.2/0178 | Pharma Dynamics (Pty) Ltd | active | 5 Sept 2028 |
| MYLAN ZOLPIDEM | A39/2.2/0348 | Viatris South Africa (Pty) Ltd | suspended | 25 Sept 2025 |
| REDINOCT 10 | 42/2.2/0721 | Dr ReddyÆs Laboratories (Pty) Ltd | suspended | 9 Apr 2025 |
| IVEDAL MR 12,5 | A40/2.2/0443 | Sanofi-Aventis South Africa (Pty) Ltd | suspended | 26 Nov 2024 |
| ZOLPIDEM 5 MG CAMOX | 50/2.2/0222 | Austell Pharmaceuticals (Pty) Ltd | active | 1 Jan 1900 |
| ZOLPIDEM 5 MG APEX | 50/2.2/0220 | Austell Pharmaceuticals (Pty) Ltd | active | 1 Jan 1900 |
| ZOLPIHEXAL 10 | 36/2.2/0095 | HEXAL PHARMA (SA) (PTY) LTD | active | 1 Jan 1900 |
| ZOLPIDEM 5 MG AUSTELL | 50/2.2/0218 | Austell Pharmaceuticals (Pty) Ltd | active | 1 Jan 1900 |
| ZOLPIDEM 10 MG AUSTELL | 50/2.2/0219 | Austell Pharmaceuticals (Pty) Ltd | active | 1 Jan 1900 |
| NOXIDEM 10 | 36/2.2/0087 | Sandoz South Africa (Pty) Ltd | active | 1 Jan 1900 |
| ZOLPIDEM 10 MG CAMOX | 50/2.2/0223 | Austell Pharmaceuticals (Pty) Ltd | active | 1 Jan 1900 |
| ZOLPIDEM 10 MG APEX | 50/2.2/0221 | Austell Pharmaceuticals (Pty) Ltd | active | 1 Jan 1900 |
Zolpidem Tartrate — SAHPRA Registration Details
SAHPRA (South Africa) has 15 registered products containing Zolpidem Tartrate, of which 12 are currently active. Data is sourced directly from the official SAHPRA drug register and refreshed daily.
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