Africa Pharma Registrations: 40 Expirations in Next 90 Days (June 2026)
40 pharmaceutical registrations across five African countries, including essential medicines and key generics, are set to expire by June 2026. This data highlights critical regulatory management needs.
A critical analysis of regulatory intelligence data reveals that 40 pharmaceutical product registrations across five African countries are slated to expire in the next 90 days, specifically by June 2026. This impending wave of expirations, identified through robust market surveillance, underscores the continuous and often complex regulatory demands faced by pharmaceutical companies operating in the region.
Key Expirations and Market Impact
The expiring registrations span a range of therapeutic areas and include several essential medicines and key generics. Côte d'Ivoire accounts for a significant portion of these expirations, with 16 products, followed by Zambia with 13, Nigeria with 5, and South Africa and Kenya each with 2 expirations within this 90-day window.
Dominant Product Categories and Holders
Several critical drug classes are represented in these upcoming expirations:
- Antimalarials: Products like COFANTRINE ADULTES (Artemether+Lumefantrine) in Côte d'Ivoire and Lomasyl Forte Tablets (Artemether; Lumefantrine) in Nigeria are vital for a region where malaria remains endemic. Their expiration could impact treatment availability if not renewed promptly.
- Antibiotics: AUGMENTIN (Amoxicillin+Clavulanic Acid) and ZOMAX (Azithromycin) in Côte d'Ivoire, both widely used antibiotics, highlight the need for continuous supply lines.
- Cardiovascular Drugs: BIPRETERAX ARGININE and PRETERAX ARGININE (Perindopril Arginine+Indapamide) from Les Laboratoires Servier in Côte d'Ivoire are important for managing hypertension.
- Pain Management and Anti-inflammatories: Drugs like TRAMACETAL (Tramadol+Paracetamol) in Côte d'Ivoire, LYSER D (Diclofenac Sodium & Serratiopeptidase) in Kenya, and Aceclofen Tablet (Aceclofenac) in Nigeria are crucial for pain and inflammation relief.
- Oncology: ABITIG and ABARINE (Abiraterone Acetate) in South Africa are significant oncology treatments, and their lapse could disrupt access for cancer patients.
Large, established holders such as PIERRE FABRE MEDICAMENT, GLAXOSMITHKLINE EXPORT LTD, GLENMARK PHARMACEUTICALS LIMITED, LES LABORATOIRES SERVIER, and Ranbaxy Pharmaceutical (Pty) Ltd feature prominently among those with expiring registrations. Their proactive management of these renewals is paramount to maintaining market presence and patient access.
Detailed List of Expiring Registrations (Next 90 Days)
| Drug | Holder | Country | Expiry Date | Reg No |
|---|---|---|---|---|
| PRIMALAN 10MG COMPRIME SECABLE BOITE DE 10 (MEQUITAZINE) | PIERRE FABRE MEDICAMENT LES CAUQUILLOUS | Côte d'Ivoire | 12 Jun 2026 | E-2006-127 |
| FEBRILEX COMPRIME BOITE DE 200 (PARACETAMOL+PHENYLEPHRINE+CHLORPHENAMINE) | EXPHAR S.A | Côte d'Ivoire | 14 Jun 2026 | E-2002-043 |
| AUGMENTIN 500MG/62,5MG COMPRIME PELLICULE BOITE DE 16 (AMOXICILLINE+ACIDE CLAVULANIQUE) | GLAXOSMITHKLINE EXPORT LTD | Côte d'Ivoire | 15 Jun 2026 | E-2001-013 |
| CANDID 1% POUDRE POUR APPLICATION CUTANEE FLACON DE 30G (CLOTRIMAZOLE) | GLENMARK PHARMACEUTICALS LIMITED | Côte d'Ivoire | 15 Jun 2026 | E-2002-003 |
| BIPRETERAX ARGININE 10MG/2,5MG COMPRIME PELLICULE BOITE DE 30 (PERINDOPRIL ARGININE+INDAPAMIDE) | LES LABORATOIRES SERVIER | Côte d'Ivoire | 16 Jun 2026 | E-2011-024 |
| BIPRETERAX ARGININE 5MG/1,25MG COMPRIME PELLICULE BOITE DE 30 (PERINDOPRIL ARGININE+INDAPAMIDE) | LES LABORATOIRES SERVIER | Côte d'Ivoire | 16 Jun 2026 | E-2011-023 |
| BUFENOL 20MG/ML SUSPENSION BUVABLE FLACON DE 120ML (IBUPROFENE) | LABORATOIRES OLEA | Côte d'Ivoire | 16 Jun 2026 | E-2011-015 |
| CEFIM 400MG GELULE BOITE DE 6 (CEFIXIME) | OMAN PHARMACEUTICAL | Côte d'Ivoire | 16 Jun 2026 | MD/201024-0198 |
| CETRAXAL PLUS 3MG/0,25MG GOUTTES AURICULAIRES FLACON DE 10ML (CIPROFLOXACINE+FLUOROCINOLONE ACETONIDE) | LABORATORIOS SALVATS.A | Côte d'Ivoire | 16 Jun 2026 | E-2006-0129 |
| COFANTRINE ADULTES 80MG/480MG COMPRIME BOITE DE 6 (ARTEMETHER+LUMEFANTRINE) | IMEX-PHARMA ROSE BELLE BUILDING | Côte d'Ivoire | 16 Jun 2026 | E-2011-0016 |
| DIAMICRON 60MG COMPRIME SECABLE A LIBERATION MODIFIEE BOITE DE 30 (GLICLAZIDE) | LES LABORATOIRES SERVIER | Côte d'Ivoire | 16 Jun 2026 | E-2011-025 |
| PRETERAX ARGININE 2,5MG/0,625MG COMPRIME PELLICULE BOITE DE 30 (PERINDOPRIL ARGININE+INDAPAMIDE) | LES LABORATOIRES SERVIER | Côte d'Ivoire | 16 Jun 2026 | E-2011-022 |
| T-FER COMPRIME PELLICULE BOITE DE 30 (ASCORBATE FERREUX +OXYDE DE ZINC+VITAMINE B12+ACIDE FOLIQUE) | TAURIAN PHARMA PVT | Côte d'Ivoire | 16 Jun 2026 | E-2011-008 |
| TRAMACETAL 325MG/37.5MG COMPRIME BOITE DE 10 (CHLORHYDRATE DE TRAMADOL+PARACETAMOL) | LABORATOIRES CACHET PHARMACEUTICALS PVT | Côte d'Ivoire | 16 Jun 2026 | E-2011-026 |
| HITKIT (COMBIKIT OF (A) Rabeprazole Sodium Tablets (B)…) | KRISHNA CHEMISTS LTD | Kenya | 17 Jun 2026 | CTD7830 |
| ETOXYM (S-ETODOLAC 300MG + PARACETAMOL 500MG) | KRISHNA CHEMISTS LTD | Kenya | 17 Jun 2026 | 24445 |
| LYSER D Tablets (Diclofenac Sodium & Serratiopeptidase Tablets) | Comed Chemicals Limited | Kenya | 19 Jun 2026 | 2006/622 |
| VERIIBEN 4% SUSPENSION BUVABLE FLACON DE 10ML (ALBENDAZOLE) | LABORATOIRES OLEA | Côte d'Ivoire | 21 Jun 2026 | E-2006-174 |
| ZOMAX 500MG COMPRIME PELLICULE BOITE DE 3 (AZITHROMYCINE) | LABORATOIRES IBN | Côte d'Ivoire | 21 Jun 2026 | E-2006-161 |
| ABITIG (each tablet contains: abiraterone acetate 250,0 mg) | Ranbaxy Pharmaceutical (Pty) Ltd | South Africa | 22 Jun 2026 | 51/21.12/0508 |
| ABARINE (each tablet contains: abiraterone acetate 250,0 mg) | Ranbaxy Pharmaceutical (Pty) Ltd | South Africa | 22 Jun 2026 | 51/21.12/0509.508 |
| Gabanerve Tablets (Gabapentin +Methycobalamin) | MEDISEL KENYA LIMITED | Zambia | 23 Jun 2026 | 516/001 |
| Farmvita Injection (Vitamin A + Vitamin D3 + Vitamin E Acetate + Nicotinamide + Thiamine HCl + Pyridoxine HCl + Riboflavin Sodium Phosphate + D-Panthenol + Vitamin B12) | FARMERS CENTRE LTD | Zambia | 23 Jun 2026 | 397/725V |
| Turbovas 10 Tablets (Rosuvastatin) | MICRO LABS LTD | Zambia | 23 Jun 2026 | 315/038 |
| Turbovas 20 Tablets (Rosuvastatin) | MICRO LABS LTD | Zambia | 23 Jun 2026 | 315/039 |
| Mipro Far Off 200 Powder (Monensin Sodium 200g) | Sano- Modern Animal Nutrition Ltd | Zambia | 23 Jun 2026 | 517/003VL |
| Mipro 300 Powder Dairy Feed Additive (Manganese Sulfate 1 - 1.8% w/w + Copper Sulfate 0.5 - 1% w/w) | Sano- Modern Animal Nutrition Ltd | Zambia | 23 Jun 2026 | 517/001VL |
| Ivercare Injection (Ivermectin) | B & B Manufacturing, LLC | Zambia | 23 Jun 2026 | 483/704V |
| Oxycare Injection (Oxytetracycline hydrochloride) | B & B Manufacturing, LLC | Zambia | 23 Jun 2026 | 483/705V |
| Drench-Mate ® Cal-Mate Bolus (Calcium Chloride + Calcium Propionate) | B & B Manufacturing, LLC | Zambia | 23 Jun 2026 | 483/703VL |
| Drench-Mate ® Elyte Dry Single Dose (Dextrose + Maltodextrin + Sodium Chloride + Sodium Acetate + Sodium Citrate + Potassium Chloride + Glycine) | B & B Manufacturing, LLC | Zambia | 23 Jun 2026 | 483/704VL |
| Penfarm Injection (Penicillin G Procaine + Dihydrostreptomycin Sulfate) | FARMERS CENTRE LTD | Zambia | 23 Jun 2026 | 397/721V |
| Albendafarm Bolus (albendazole) | FARMERS CENTRE LTD | Zambia | 23 Jun 2026 | 397/722V |
| Ivofarm Injection (Ivermectin) | FARMERS CENTRE LTD | Zambia | 23 Jun 2026 | 397/723V |
| Barclean Injection (Sulfamonomethoxine Sodium + Trimethoprim) | FARMERS CENTRE LTD | Zambia | 23 Jun 2026 | 397/724V |
| Lomasyl Forte Tablets** (Artemether; Lumefantrine) | Klusyl International Co. Ltd | Nigeria | 23 Jun 2026 | B4-3515 |
| Zinnia P Tablets# (Ethinylestradiol; Levonorgestrel) | Healthline Limited | Nigeria | 23 Jun 2026 | A4-9403 |
| Zinnia-F Tablet# (Ethinylestradiol; Levonorgestrel; Ferrous fumarate) | Healthline Limited | Nigeria | 23 Jun 2026 | B4-1145 |
| Aceclofen Tablet 100 mg_ (Aceclofenac) | Phamatex Nigeria Limited | Nigeria | 23 Jun 2026 | B4-2965 |
| Paratex Syrup (Paracetamol) | Phamatex Nigeria Limited | Nigeria | 23 Jun 2026 | B4-1594 |
Regulatory Implications of Lapsed Registrations
Lapsed pharmaceutical registrations carry significant consequences for both the pharmaceutical companies and the public health landscape of the affected countries. For companies, a primary risk is the loss of market access. Once a registration expires without timely renewal, the product can no longer be legally imported, distributed, or sold in that market. This leads to immediate revenue loss and jeopardizes investment in these regions.
Furthermore, the process of re-registration is often more arduous and time-consuming than renewal. It may involve submitting entirely new dossiers, undergoing fresh evaluations, and potentially encountering new regulatory requirements that have been introduced since the original approval. This can lead to extended periods of market absence, allowing competitors to fill the void and erode market share.
From a public health perspective, the expiration of essential medicine registrations can lead to drug shortages, particularly for critical treatments like antimalarials, antibiotics, and oncology products. Such shortages can disrupt patient care, undermine national health programs, and potentially lead to the use of substandard or falsified medicines as desperate measures. This is especially concerning in African markets where stable access to quality medicines is a persistent challenge.
Moreover, regulatory bodies maintain stringent oversight. Non-compliance, including failure to renew registrations, can result in penalties, fines, and reputational damage for pharmaceutical manufacturers. These negative consequences can extend beyond a single product or market, potentially impacting a company's standing with other regulatory authorities across the continent.
Proactive Regulatory Strategy is Key
Anticipating and managing these expiration dates is a fundamental aspect of regulatory affairs. Companies must implement robust internal tracking systems and allocate sufficient resources to prepare and submit renewal applications well in advance. Given the often-lengthy processing times in some African regulatory agencies, a proactive approach is not just advisable, but essential.
The high number of expirations within a short timeframe underscores the dynamic nature of Africa's pharmaceutical regulatory environment. Companies with a strong presence or ambitions in these markets must prioritize regulatory intelligence and compliance to avoid disruptions to their supply chains and patient access.
AfriReg Pro empowers regulatory teams to automate the tracking of pharmaceutical registrations, providing timely alerts for upcoming expirations and changes in regulatory frameworks across African markets. This proactive intelligence helps companies maintain compliance, avoid market disruptions, and strategically plan their regulatory activities.