Afriplex is excited to announce a unique range of active pharmaceutical ingredients (API), supported by fully developed active pharmaceutical ingredient master files (APIMF).
By utilising our research and development capabilities, we’ve expanded into APIMF development to support our range of API’s such as Folicin A/T and Afriplex GRT. An APIMF describes the preparation, control and stability of the API and forms the basis of Module 3.2.S of the Common Technical Document (CTD). An API can be described as the drug substance or the active ingredient of a pharmaceutical product.
Afriplex is excited to have launched this program and by working closely with research institutions such as the Council of Scientific and Industrial Research (CSIR) and the South African Medical Research Council (SAMRC), we are eager to assist our clients with the necessary safety and efficacy data needed to substantiate all claims associated with the API’s we develop and manufacture.
Please contact us for more information on our range of API’s and project timeline.