AfricaRegulatory
African Pharmaceutical Regulatory Intelligence
ISOTRETINOIN
32 registrations across 5 African markets— 32 active
Markets with ISOTRETINOIN
Recent registrations
| Brand / Product | Market | Holder | Status | Expires |
|---|---|---|---|---|
| ORATANE 40MG CAPSULES (Each soft gelatin capsule contains Isotretinoin 40mg) | 🇬🇭Ghana | — | active | Apr 2031 |
| ORATANE 40MG CAPSULES (Each soft gelatin capsule contains Isotretinoin 40mg) | 🇬🇭Ghana | — | active | Apr 2031 |
| ORATANE 20 CAPSULES (Each soft gelatin capsule contains Isotretinoin 20mg) | 🇬🇭Ghana | — | active | Apr 2031 |
| ORATANE 20 CAPSULES (Each soft gelatin capsule contains Isotretinoin 20mg) | 🇬🇭Ghana | — | active | Apr 2031 |
| ORATANE 10 CAPSULES (Each soft gelatin capsule contains Isotretinoin 10 mg) | 🇬🇭Ghana | — | active | Apr 2031 |
| ORATANE 10 CAPSULES (Each soft gelatin capsule contains Isotretinoin 10 mg) | 🇬🇭Ghana | — | active | Apr 2031 |
| IMANOK CAPSULES (Each soft gelatin capsule contains Isotretinoin 10mg) | 🇬🇭Ghana | — | active | Feb 2031 |
| IMANOK CAPSULES (Each soft gelatin capsule contains Isotretinoin 10mg) | 🇬🇭Ghana | — | active | Feb 2031 |
| Cosmin Gel (null smpc) Gel | 🇳🇬Nigeria | Nurushat Ventures Limited | active | Dec 2026 |
| ORATANE 40 mg | 🇿🇦South Africa | ACINO PHARMA (PTY) LTD | active | Jan 1900 |
| SUPATANE 8 mg | 🇿🇦South Africa | Austell Pharmaceuticals (Pty) Ltd | active | Jan 1900 |
| SUPATANE 16 mg | 🇿🇦South Africa | Austell Pharmaceuticals (Pty) Ltd | active | Jan 1900 |
| ROACCUTANE 20 mg CAPSULES | 🇿🇦South Africa | Equity Pharmaceutical (Pty) Ltd | active | Jan 1900 |
| ACNETRET 20 | 🇿🇦South Africa | Cipla Medpro (Pty) Ltd | active | Jan 1900 |
| ROACCUTANE 10 mg | 🇿🇦South Africa | Equity Pharmaceutical (Pty) Ltd | active | Jan 1900 |
| ACNETANE 10 mg | 🇿🇦South Africa | Adcock Ingram Limited | active | Jan 1900 |
| ACNETRET 10 | 🇿🇦South Africa | Cipla Medpro (Pty) Ltd | active | Jan 1900 |
| ACNETANE 20 mg | 🇿🇦South Africa | Adcock Ingram Limited | active | Jan 1900 |
| ISOTRETINOIN ORAL SOLID
ORDINARY
OTHER
CAPSULES | 🇺🇬Uganda | ACINO PHARMA (PTY) LTD | active | — |
| A-cnotren Capsules | 🇹🇿Tanzania | Pharmathen S.A. | active | — |
| Oratane 10 mg Soft Gelatin Capsule | 🇹🇿Tanzania | Acino Pharma (Pty) Ltd | active | — |
| Oratane 20 Soft Gelatin Capsule | 🇹🇿Tanzania | Acino Pharma (Pty) Ltd | active | — |
| Oratane 40 Capsules, soft | 🇹🇿Tanzania | Acino Pharma (Pty) Ltd | active | — |
| ISOTRETINOIN ORAL SOLID
ORDINARY
OTHER
CAPSULES | 🇺🇬Uganda | ACINO PHARMA (PTY) LTD | active | — |
| Acnotin 20 Softgel Tablets | 🇹🇿Tanzania | Mega Lifesciences Public Company Limited | active | — |
| ISOTRETINOIN ORAL SOLID
ORDINARY OTHER
CAPSULES | 🇺🇬Uganda | MEGA LIFESCIENCES (AUSTRALIA) PTY LTD | active | — |
| Acnotin 10 Capsules, soft | 🇹🇿Tanzania | Mega Lifesciences Public Company Limited | active | — |
| ISOTRETINOIN ORAL SOLID
ORDINARY
OTHER
CAPSULES | 🇺🇬Uganda | MEGA LIFESCIENCES (AUSTRALIA) PTY LTD | active | — |
| ISOTRETINOIN ORAL SOLID
ORDINARY OTHER
CAPSULES | 🇺🇬Uganda | ACINO PHARMA (PTY) LTD | active | — |
| ISOTRETINOIN ORAL SOLID
ORDINARY
OTHER
CAPSULES | 🇺🇬Uganda | MEGA LIFESCIENCES (AUSTRALIA) PTY LTD | active | — |
| ISOTRETINOIN ORAL SOLID
ORDINARY OTHER
CAPSULES | 🇺🇬Uganda | ACINO PHARMA (PTY) LTD | active | — |
| ISOTRETINOIN ORAL SOLID
ORDINARY OTHER
CAPSULES | 🇺🇬Uganda | MEGA LIFESCIENCES (AUSTRALIA) PTY LTD | active | — |
ISOTRETINOIN in Africa — Regulatory Overview
ISOTRETINOIN is registered across 5 African markets with 32 total product registrations on file. Data is sourced directly from official national drug regulatory authorities including South Africa, Ghana, Uganda, Tanzania and 1 more. AfricaRegulatory refreshes this data daily from official government sources.
Of the 32 registrations, 32 (100%) 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.