KDU offers bioequivalence studies for pharmaceutical companies
July 04, 2022• KDU signs MOUs with Navesta Pharmaceuticals for two Bioequivalence Projects
General Sir John Kotelawala Defence University (KDU) offers bioequivalence (BE) studies for pharmaceutical companies.
KDU has successfully performed and completed several BE studies and also is known as the only institute in the island that offers commercial BE studies.
Therefore, pharmaceutical companies continue to forward their BE study requests to KDU and two recent requests from Navesta Pharmaceuticals were accepted, KDU sources said.
Indicating the new guidelines of National Medicines Regulatory Authority, which requires pharmaceutical companies to obtain a report on BE for their respective drugs as a registration requirement, the KDU said such companies receive their BE studies through outsourcing overseas which is costly and complex.
Two MOUs were signed between KDU and Navesta Pharmaceuticals recently (July 01) in order to carry out two BE studies for Flucloxacillin and Co-Amoxiclav, the KDU added.
KDU Vice-Chancellor Major General Milinda Peiris and Prof. Thushara Weerawardane, Director, Institute of Combinatorial Advanced Research and Education (KDU-CARE), signed the agreement on behalf of the KDU.
Dr. Janaka Wickramasinghe, Director/COO, and Amitkumar Ashokbhai Prajapati, Head of Plants of Navesta Pharmaceuticals signed the agreement for 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 were also present at the occasion.
The way forward of the projects and future scope with other BE studies were also discussed during the session, the KDU also said.