Aspen Pharmacare has secured a landmark regulatory win after the South African Health Products Regulatory Authority (Sahpra) approved the commercial release of Aspen’s first locally manufactured human insulin batches. The products are cleared for sale in South Africa and other African markets, moving the project from planning into live supply for patients and health systems. Aspen produces the insulin at…
Tag: Pharmaceutical Manufacturing
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Lenacapavir Manufacturing In SA: Strengthening Production
A new wave of “America First” industrial policy is reshaping global supply chains. Medicines and vaccines are increasingly treated as strategic assets, not just commercial products. That shift matters for South Africa, which still relies heavily on imports for essential health technologies, making discussions around Lenacapavir Manufacturing in SA increasingly important. The COVID-19 pandemic exposed how quickly supply lines can…
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Cholera Vaccine Trial Aims for Self-Reliance in Africa
South Africa has taken a pivotal step towards pharmaceutical independence with the launch of a new South African cholera vaccine trial. The state-backed manufacturer, Biovac, in partnership with the South African Medical Research Council (SAMRC), has initiated clinical trials for a candidate oral cholera vaccine. Many hail this development as a crucial move to reduce Africa’s dependence on imported medicines.…
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Aspen Pharmacare Dispute Ends with R500m Settlement
Aspen Pharmacare is set to receive a R500m windfall following the resolution of a damaging legal battle with an undisclosed manufacturing client. This closes a seven-month chapter of significant financial uncertainty for Africa’s largest pharmaceutical producer. In a statement, Aspen advised shareholders that the dispute had been settled. The counterparty is required to pay the R500m “before December 1 2025,…
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Aspen Pharmacare Manufacturing Dispute Shrouded in Mystery
ASPEN Pharmacare has issued a stark warning to investors. They are signalling a potential R2 billion plunge in core earnings for its 2025 financial year. This is due to the significant Aspen Pharmacare manufacturing dispute detailed this week. In a regulatory filing on Tuesday, Aspen alerted shareholders to emerging risks. It highlighted a “material contractual dispute” with an unnamed contract…
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African Pharmaceutical Procurement: A Path to Self-Sufficiency
A pooled system for African pharmaceutical procurement is crucial. Africa must reduce its dependence on imported medicines. Delegates at a G20 event reached this conclusion. The discussion highlighted Africa’s vulnerability in its supply chain. The COVID-19 pandemic exposed this. Recent US and European aid cuts emphasised this. The Need for African Pharmaceutical Procurement Africa’s lack of local production is a…
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FDA warns Aspen Pharmacare over eye drop production standards
The US Food and Drug Administration (FDA) has raised serious concerns regarding the manufacturing standards of eye drops produced by Aspen Pharmacare at its sterile facility in Gqeberha, South Africa. In a warning letter, the FDA highlighted potential risks of microbial contamination due to inadequate controls. The FDA’s warning letter, published following a September audit, revealed that Aspen’s manufacturing processes…