CBS-KDU CARE Successfully Completes Bioequivalence Study of Metformin for Astron Limited

The Centre for Bioequivalence Studies (CBS) at the Institute for Combinatorial Advanced Research and Education (KDU-CARE) of KDU has successfully completed the Bioequivalence (BE) study on Metformin SR 500 mg, manufactured by Astron Limited. The final report was officially handed over by Rear Admiral HGU Dammika Kumara, VSV, USP, psc, MMaritimePol, BSc (DS), Vice-Chancellor of KDU, to Ms. Marise Deckker, Managing Director of Astron Limited, on August 11th, 2024.

Astron Limited was represented by Mr. Sirimal Fernando, Director/Chief Executive Officer; Mr. Johann De Zilwa, COM/Director Marketing; Dr. Malindra Badathuruge, General Manager of Quality Operations; Mrs. Shanika Fernando, HOD/Assistant General Manager of Research & Development; and Mr. Tharindu Mihiran, Assistant Manager of Regulatory Affairs. KDU was represented by Prof. Thushara Weerawardane, Director of KDU-CARE; Senior Prof. Rohini Fernandopulle, WHO National Consultant on Regulatory Functions to NMRA; and the principal investigators of the project, Prof. Pandula Athauda-arachchi, Consultant Interventional Cardiologist (UK & SL Board Certified), and Dr. Himali Jayasinghearachchi, along with Consultant physicians Dr. T.M. Munasinghe and Prof. Priyamali Jayasekara.

During the event, the Vice-Chancellor emphasized the immense potential KDU holds in driving national development through industry collaboration. Ms. Marise Deckker praised the team for their dedication and successful completion of the Bioequivalence (BE) study on Metformin, in full compliance with the requirements of Sri Lanka’s National Medicines Regulatory Authority (NMRA).

Further discussions explored future collaboration opportunities, focusing on BE studies, medicine quality assurance, and research and development (R&D) efforts to create new drug formulations. As a leading university in Sri Lanka, KDU is now well-positioned to address local demand for BE studies, utilizing advanced research laboratories at KDU and KDU Hospital. To date, KDU-CARE has successfully completed BE studies on Amoxicillin and Clarithromycin for the State Pharmaceuticals Manufacturing Corporation (SPMC), as well as three BE studies on Metformin for CIC Holdings, Gamma InterPharm (Pvt) Ltd, and Astron Limited. The BE study on Gliclazide 60 mg MR for Gamma InterPharm (Pvt) Ltd is currently nearing completion.