AfricaRegulatory

African Pharmaceutical Regulatory Intelligence

Amlodipine Besylate USP

12 registrations across 4 African markets— 9 active

Markets with Amlodipine Besylate USP

Recent registrations

Brand / ProductMarketHolderStatusExpires
Amlowin -10 tablets
Tablet Uncoated
🇿🇲ZambiaMMC Healthcare LimitedactiveJun 2031
BDA AMLOSIVE 5
Un coated Tablets
🇷🇼RwandaCENTURY PHARMACEUTICAL LIMITEDactiveMay 2031
AMLOFON 10 TABLETS (Each uncoated tablet contains Amlodipine Besylate USP 10mg)🇬🇭GhanaactiveMay 2031
AMLOFON 10 TABLETS (Each uncoated tablet contains Amlodipine Besylate USP 10mg)🇬🇭GhanaactiveMay 2031
AMLOFON 5 TABLETS (Each uncoated tablet contains Amlodipine Besylate USP 5mg)🇬🇭GhanaactiveMay 2031
AMLOFON 5 TABLETS (Each uncoated tablet contains Amlodipine Besylate USP 5mg)🇬🇭GhanaactiveMay 2031
Varinil 10mg Tablets
Uncoated Tablet
🇿🇲ZambiaCOSMOS LTDactiveJul 2030
AMLOSIN 10
Tablets
🇷🇼RwandaHetero Labs LtdactiveAug 2029
AMLOSIN 5
Tablets
🇷🇼RwandaHetero Labs LtdactiveAug 2029
ZYROPIN TABLETS
2 X 14
🇳🇬NigeriaONIFAM LABORATORIES LTD. SUITE C5expiredMar 2022
AMLODIPINE BESYLATE TABLETS
1 X 10
🇳🇬NigeriaABSA HEALTHCARE LTD 100expiredMar 2022
AMLODIPINE BESYLATE TABLETS
1 X 10
🇳🇬NigeriaABSA HEALTHCARE LTD 100expiredMar 2022

Amlodipine Besylate USP in Africa — Regulatory Overview

Amlodipine Besylate USP is registered across 4 African markets with 12 total product registrations on file. Data is sourced directly from official national drug regulatory authorities including Ghana, Nigeria, Rwanda, Zambia. AfricaRegulatory refreshes this data daily from official government sources.

Of the 12 registrations, 9 (75%) 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.