Quality · Compliance
Regulatory excellence
LHC Pharma operates with the highest standards of pharmaceutical regulation and compliance. Every product distributed in South Africa is registered with the South African Health Products Regulatory Authority (SAHPRA), ensuring adherence to stringent safety, efficacy, and quality standards.
Our commitment is reflected in a robust pipeline of more than twenty-five pending dossiers, tracked transparently through SAHPRA's submission system, demonstrating our ongoing investment in expanding our therapeutic portfolio.
SAHPRA's strategic position in the global pharmaceutical landscape is strengthened through its membership in the World Health Organization (WHO) Prequalification Programme, its participation in the Pharmaceutical Inspection Co-operation Scheme (PIC/S), and its recent accession to the International Council for Harmonisation (ICH). Through alignment with these world-class regulatory networks, our products meet not only rigorous local requirements but internationally recognised standards for pharmaceutical quality, safety, and efficacy.
SAHPRA
South African Health Products Regulatory Authority
WHO PQ
WHO Prequalification Programme
PIC/S
Pharmaceutical Inspection Co-operation Scheme
ICH
International Council for Harmonisation
Every LHC product distributed in South Africa is registered with the South African Health Products Regulatory Authority, the national body responsible for the registration, licensing, and ongoing oversight of medicines, medical devices, and clinical trials. Registration is not a one-time stamp. It is a continuous obligation that includes batch reporting, adverse-event tracking, and periodic re-evaluation. Our regulatory team manages this work full-time.
Our flagship contract manufacturer is KRKA Pharmaceuticals in Slovenia. KRKA's facilities meet European GMP standards and produce medicines registered in jurisdictions worldwide. Where KRKA does not produce a given line, we work exclusively with European manufacturers of comparable accreditation. Every batch we distribute is traceable to its manufacturing source.
Our regulatory and quality function is led full-time by Ms Sekie Shaku. The team manages the dossier pipeline, SAHPRA submissions, post-marketing surveillance, and adverse-event reporting. They report directly to the Medical Director.
We currently have more than twenty-five active dossier applications in review with SAHPRA. Our Linezolid LHC application has received Fast-Track status, granted by the regulator in recognition of submission quality and the public-health value of the molecule for tuberculosis treatment.
If you are a healthcare professional and need to report an adverse event involving an LHC product, please contact us at: pharmacovigilance@lhcpharma.com · +27 12 804 5617. We acknowledge all reports within one business day.
