Completed Projects

KDU-CARE Successfully Completes the Bioequivalence Study of Clarithromycin for SPMC

 

The CARE Technology Lanka (Pvt) Ltd of the Institute for Combinatorial Advanced Research and Education (KDU-CARE) of KDU has successfully completed the Bioequivalence (BE) study on Metformin extended-release for CIC Holdings PLC. The final report was submitted by the Vice-Chancellor of KDU Major General Milinda Peiris to Aroshan Seresinhe, Group Chief Executive Officer of CIC Holdings PLC on the 17th of June 2022. Mr. Viraj Manathunga – Divisional Director of Pharmaceuticals & Sales, Mr. Thiliak Haputhathri – Head of Regulatory Affairs, and Sanjaya Rathnayake – Business Development Manager, represented the CIC Holdings PLC on this occasion. Prof. Thushara Weerawardane – Director, KDU-CARE, Snr. Prof Rohini Fernandopulle – WHO National Consultant on Regulatory Functions to NMRA, Prof. Charitha Gunasekara – Former Acting Director, KDU-CARE, Dr. Himali Jayasinghearachchi, Principal Investigator, and Dr. Pandula Athauda-arachchi, Consultant Interventional Cardiologist (UK & SL Board Certified) also participated in this occasion.

 

During the discussion, CIC Holdings agreed on a new BE project on Azithromycin as the KDU-CARE was able to successfully complete the BE studies on Metformin as per the requirements of NMRA of Sri Lanka despite the crises in the country. Further discussions were made for future collaborative BE studies with local and foreign partners on several other imported and locally manufactured drugs.

 

Greater demand for BE studies has been created over the past couple of years due to the exponential growth of the local pharmaceutical industry. As a leading university in Sri Lanka, KDU is now capable of catering to the local demand for BE studies by utilizing its Smart Hospital and the State-Of-The-Art Research Laboratories. So far, KDU-CARE has successfully completed BE studies on Amoxicillin and Clarithromycin for SPMC and two BE projects are currently undergoing for Interpharm (Pvt.) Ltd. & Gamma Pharmaceuticals (Pvt.) Ltd which are in their final stages. All these BE requests from pharma companies are carried out following FDA protocols by a team of scientists, from KDU-CARE and the Faculty of Medicine-KDU, headed by Prof. Rohini Fernandopulle, Dr. Himali Jayasinghearachchi, Dr. Janaka Munasinghe, Dr. Panduala Athauda-arachi and an expert panel of senior academic and professional staff.

 

In addition, CIC Holdings has further discussed possible new directions of collaborations with KDU regarding herbal plantations and their respective analytical & clinical studies. The importance of the cultivation of nationally significant herbal and ayurvedic plants on Sri Lankan soil to mitigate the excessive imports and hence boost the Sri Lankan economy by preserving foreign reserves was also highlighted during the discussion.

KDU-CARE Successfully Completes the Bioequivalence Study of Clarithromycin for SPMC

The Institute for Combinatorial Advanced Research and Education of KDU (KDU-CARE), successfully completed the Bioequivalence (BE) study of Clarithromycin for the State Pharmaceutical Manufacturing Corporation (SPMC).

 

 

 

The final report of the study was submitted to the Chairman of SPMC, Dr Uthpala Indrawansa and his team, by the Vice Chancellor of KDU, Director-KDU-CARE and the research team, on 1st December 2020.

The project was undertaken by the KDU-CARE, and was led by a team of scientists, from KDU-CARE and the Faculty of Medicine-KDU, Prof. Rohini Fernandopullei, Dr. Himali Jayasinghearachchi, Dr. Darshana De Silva, Dr. Janaka Munasinghe and Dr. Prasad Premaratne.