According to the new National Medicines Regulatory Authority (NMRA) guidelines, pharmaceutical companies must obtain a report on bioequivalence (BE) for their respective drugs as a registration requirement. Until recently, all pharmaceutical companies got BE studies done by outsourcing to different other countries which is a costly and inconvenient process. Currently, General Sir John Kotelawala Defence University is offering BE studies for pharmaceutical companies and is the only institute in Sri Lanka that offers commercial BE studies. KDU has successfully carried out and completed several BE studies to date. Pharmaceutical companies continue to forward their BE study requests to KDU. Two new requests from Navesta Pharmaceuticals were accepted by KDU.
Two MOUs were signed between General Sir John Kotelawala Defence University and Navesta Pharmaceuticals on the 01st of July 2022 to carry out two BE studies for Flucloxacillin and Co-Amoxiclav. Major General Milinda Peiris, the Vice-Chancellor, Prof. Thushara Weerawardane, Director, Institute of Combinatorial Advanced Research and Education (KDU-CARE), signed the agreement on behalf of General Sir John Kotelawala Defence University. Dr. Janaka Wickramasinghe, Director/COO, and Amitkumar Ashokbhai Prajapati, Head of Plants of Navesta Pharmaceuticals signed the agreement on behalf of Navesta Pharmaceuticals (Pvt) Ltd. Senior Prof Rohini Fernandopulle – WHO National Consultant on Regulatory Functions to NMRA, Lt. Col. Dr. PH Pemarathne, Assistant Director/KDU-CARE, Dr. Pandula Athaudaarachchi, Consultant Interventional Cardiologist & the Clinical Principal Investigator, Dr. Himali Jayasinghearachchi, Senior Bioanalytical Principal Investigator, and Dr. Nadeesha Rathuwadu, Bioanalytical Principal Investigator also participated in this occasion. The way forward of the projects and future scope with other BE studies were also discussed at this occasion.
MOU signed with CIC Holdings PVT Ltd for bioequivalence study on metformin 500 mg tablets (Generic, CIC Holdings PVT Ltd (CIC) and Glucophage XR 500 mg tablets (Merck Sante S A S, France), in healthy subjects under fasting conditions.
MOU signed with Interpharm PVT Ltd for bioequivalence study on metformin 500 mg tablets (Generic, Generic, Interpharm PVT Ltd) and Glucophage XR 500 mg tablets (Merck Sante S A S, France), in healthy subjects under fasting conditions