AfricaRegulatory
African Pharmaceutical Regulatory Intelligence
AMITRIPTYLINE HYDROCHLORIDE
39 registrations across 6 African markets— 25 active
Markets with AMITRIPTYLINE HYDROCHLORIDE
Recent registrations
| Brand / Product | Market | Holder | Status | Expires |
|---|---|---|---|---|
| ZIVIGAN 25 mg | 🇿🇦South Africa | Dezzo Trading 392 (Pty) Ltd | active | Nov 2029 |
| ZIVIGAN 10 mg | 🇿🇦South Africa | Dezzo Trading 392 (Pty) Ltd | active | Nov 2029 |
| ZIVIGAN 50 mg | 🇿🇦South Africa | Dezzo Trading 392 (Pty) Ltd | active | Nov 2029 |
| AMIROL 25 TABLET, COATED; ORAL | 🇿🇼Zimbabwe | REMEDICA LTD | active | Dec 2027 |
| APO-AMITRIPTYLINE TABLET, COATED; ORAL | 🇿🇼Zimbabwe | APOTEX INC. | active | Dec 2027 |
| TRIDEP-25 TABLET, COATED; ORAL | 🇿🇼Zimbabwe | TORRENT PHARMACEUTICALS | active | Dec 2027 |
| TRYPTAL TABLET, COATED; ORAL | 🇿🇼Zimbabwe | CAPS PVT LTD | active | Dec 2027 |
| AMITRIP 25MG TABLETS Film Coated Tablets | 🇷🇼Rwanda | LABORATORY & ALLIED LTD | active | Oct 2027 |
| Joncine Tablets Tablet | 🇳🇬Nigeria | Jonco Pharmaceutical Company Ltd | active | Oct 2026 |
| Amitryptylline HCl Tablets** Tablet | 🇳🇬Nigeria | Manfes Pharmaceutical Company Limited | active | Aug 2026 |
| Amyvil 25 Tablet_ Tablet | 🇳🇬Nigeria | Zolon Healthcare Limited | active | Jun 2026 |
| ADCO-AMITRYPTILINE 25 | 🇿🇦South Africa | Adcock Ingram Limited | suspended | Jun 2025 |
| AMILEB-25 25MG TABLET TABLET | 🇲🇼Malawi | — | expired | Mar 2025 |
| NORILINE 25 mg | 🇿🇦South Africa | Pharmacare Limited û Woodmead | suspended | Jul 2024 |
| NORILINE 10 mg | 🇿🇦South Africa | Pharmacare Limited û Woodmead | suspended | Jul 2024 |
| DETRYP 50 mg | 🇿🇦South Africa | Pharma Dynamics (Pty) Ltd | suspended | Jul 2023 |
| DETRYP 10 mg | 🇿🇦South Africa | Pharma Dynamics (Pty) Ltd | suspended | Jul 2023 |
| ZYTRIP 10 mg | 🇿🇦South Africa | Pharma Dynamics (Pty) Ltd | suspended | Jul 2023 |
| DETRYP 25 mg | 🇿🇦South Africa | Pharma Dynamics (Pty) Ltd | suspended | Jul 2023 |
| ZYTRIP 25 mg | 🇿🇦South Africa | Pharma Dynamics (Pty) Ltd | suspended | Jul 2023 |
| ZYTRIP 50 mg | 🇿🇦South Africa | Pharma Dynamics (Pty) Ltd | suspended | Jul 2023 |
| LIMBITROL-F | 🇿🇦South Africa | Pharmaco Distribution (Pty) Ltd | suspended | Jun 2022 |
| AMITRIPTYLINE 25MG TABLET TABLET | 🇲🇼Malawi | — | expired | Dec 2003 |
| AMIROL 10MG TABLET TABLET | 🇲🇼Malawi | — | expired | Aug 2003 |
| AMIROL-25 25MG TABLET TABLET | 🇲🇼Malawi | — | expired | Aug 2003 |
| TREPILINE - 25 | 🇿🇦South Africa | Pharmacare Limited û Woodmead | active | Jan 1900 |
| TREPILINE - 10 | 🇿🇦South Africa | Pharmacare Limited û Woodmead | active | Jan 1900 |
| LIMBITROL | 🇿🇦South Africa | MEDA PHARMA SA (PTY) LTD | active | Jan 1900 |
| GSA-AMITRIPTYLINE 10 | 🇿🇦South Africa | Adcock Ingram Limited | active | Jan 1900 |
| AMINEURIN 50 | 🇿🇦South Africa | Oethmaan Biosims (Pty) Ltd | active | Jan 1900 |
| AMITRIPTYLINE HCL 25 KIARA | 🇿🇦South Africa | Kiara Health (Pty) Ltd | active | Jan 1900 |
| AMITRIPTYLINE
HYDROCHLORIDE ORAL SOLID
ORDINARY FILM-
COATED
TABLETS | 🇺🇬Uganda | PINNACLE LIFE SCIENCE PVT. LTD | active | — |
| AMITRIPTYLINE
HYDROCHLORIDE ORAL SOLID
ORDINARY
TABLETS | 🇺🇬Uganda | PSYCHOTROPICS INDIA LIMITED. | active | — |
| AMITRIPTYLINE
HYDROCHLORIDE ORAL SOLID
ORDINARY FILM-
COATED TABLETS | 🇺🇬Uganda | PINNACLE LIFE SCIENCE PVT. LTD | active | — |
| AMITRIPTYLINE
HYDROCHLORIDE ORAL SOLID
ORDINARY
TABLETS | 🇺🇬Uganda | PSYCHOTROPICS INDIA LIMITED. | active | — |
| AMITRIPTYLINE
HYDROCHLORIDE ORAL SOLID
ORDINARY TABLETS | 🇺🇬Uganda | PSYCHOTROPICS INDIA LIMITED. | active | — |
| AMITRIPTYLINE
HYDROCHLORIDE ORAL SOLID
ORDINARY FILM-
COATED
TABLETS | 🇺🇬Uganda | PINNACLE LIFE SCIENCE PVT. LTD | active | — |
| AMITRIPTYLINE
HYDROCHLORIDE ORAL SOLID
ORDINARY FILM-
COATED TABLETS | 🇺🇬Uganda | PINNACLE LIFE SCIENCE PVT. LTD | active | — |
| AMITRIPTYLINE
HYDROCHLORIDE ORAL SOLID
ORDINARY TABLETS | 🇺🇬Uganda | PSYCHOTROPICS INDIA LIMITED. | active | — |
AMITRIPTYLINE HYDROCHLORIDE in Africa — Regulatory Overview
AMITRIPTYLINE HYDROCHLORIDE is registered across 6 African markets with 39 total product registrations on file. Data is sourced directly from official national drug regulatory authorities including South Africa, Uganda, Malawi, Zimbabwe and 2 more. AfricaRegulatory refreshes this data daily from official government sources.
Of the 39 registrations, 25 (64%) 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.