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African Pharmaceutical Regulatory Intelligence

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ZOPICLONE

23 registrations across 4 African markets— 22 active

Markets with ZOPICLONE

🇿🇦South Africa
17 registrations
16 active
🇳🇬Nigeria
3 registrations
3 active
🇿🇼Zimbabwe
2 registrations
2 active
🇲🇦Morocco
1 registration
1 active

Recent registrations

Brand / ProductMarketHolderStatusExpires
ZOPICLONE 7,5 INNOVATA🇿🇦South AfricaInnovata PharmaceuticalsactiveOct 2029
N/A
TABLET, COATED; ORAL
🇿🇼ZimbabweINNOVATA PHARMACEUTICALS (PTY) LTDactiveSept 2029
ZOPIMAC 3
TABLET, COATED; ORAL
🇿🇼ZimbabweMACLEODS PHARMACEUTICALS LIMITEDactiveOct 2028
Nitress Tablets
Tablet
🇳🇬NigeriaTeta Pharmaceuticals Nig LtdactiveFeb 2028
Zopice Tablet#
Tablet
🇳🇬NigeriaBio-Generics Nigeria LimitedactiveJun 2026
Zopimax Tablets# (wrong smpc)
Tablet
🇳🇬NigeriaKorlyns Pharmaceuticals LtdactiveDec 2025
PROPAN ZOPICLONE🇿🇦South AfricaAdcock Ingram LimitedsuspendedSept 2025
AUSTOVANE 3,75 mg🇿🇦South AfricaAustell Pharmaceuticals (Pty) LtdactiveJan 1900
ZOPICLONE 7,5 MG UNICORN🇿🇦South AfricaAustell Pharmaceuticals (Pty) LtdactiveJan 1900
Z-DORM🇿🇦South AfricaKiara Health (Pty) LtdactiveJan 1900
ALCHERA🇿🇦South AfricaPharmacare Limited û WoodmeadactiveJan 1900
ZOPIGEN🇿🇦South AfricaViatris South Africa (Pty) LtdactiveJan 1900
AUSTOVANE 7,5 mg🇿🇦South AfricaAustell Pharmaceuticals (Pty) LtdactiveJan 1900
SEDASTELL 3,75 mg🇿🇦South AfricaAustell Pharmaceuticals (Pty) LtdactiveJan 1900
SEDASTELL 7,5 mg🇿🇦South AfricaAustell Pharmaceuticals (Pty) LtdactiveJan 1900
ZOPISLEEP🇿🇦South AfricaiPharma (Pty) LtdactiveJan 1900
ZOPICLONE 7,5 mg AUSTELL🇿🇦South AfricaAustell Pharmaceuticals (Pty) LtdactiveJan 1900
SANDOZ ZOPICLONE 7,5🇿🇦South AfricaSandoz South Africa (Pty) LtdactiveJan 1900
ZOPIVANE🇿🇦South AfricaCipla Medpro (Pty) LtdactiveJan 1900
BIO ZOPICLONE 7,5🇿🇦South AfricaBiotech Laboratories (Pty) LtdactiveJan 1900
ADCO ZOPIMED🇿🇦South AfricaAdcock Ingram LimitedactiveJan 1900
Z-DORM HS🇿🇦South AfricaOethmaan Biosims (Pty) LtdactiveJan 1900
IMOVANE
COMPRIME PELLICULE SECABLE
🇲🇦Morocco—active—

ZOPICLONE in Africa — Regulatory Overview

ZOPICLONE is registered across 4 African markets with 23 total product registrations on file. Data is sourced directly from official national drug regulatory authorities including South Africa, Nigeria, Zimbabwe, Morocco. AfricaRegulatory refreshes this data daily from official government sources.

Of the 23 registrations, 22 (96%) 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.