Research and Development (R&D)

         SMC Research and Development section is well equipped with lab-scale equipments to enable proper Formulation & Development of pharmaceutical finished dosage form formulation.

The accredited Laboratory which is equipped with the most modern sophisticated instruments supports all the developmental work for new analytical method development, providing support for Formulation and Development.

The department is well equipped with highly sophisticated instruments like LC MS, High Performance Liquid Chromatography, FTNIR , spectrophotometers and dissolution apparatus. In addition, walk in stability chambers with data logger software help support stability studies according to PICs guideline.

Clinical Study

         A number of independent clinical trials, bio-equivalence studies and permeability studies have been undertaken to demonstrate the efficacy of SMC products compared to the original products.

Clinical trial for our product Zimmex was carried out by wellknown cardiologists and endocrinologist in 3 major School of Medicine Hospitals, namely Chulalongkorn Hospital, Siriraj Hospital, and Bhumibol Army Hospital.

The bioequivalence study of Zimmex 40 mg was carried out at Info Kinetics Sdn Bhd/Gleneagles Clinical Research Center in accordance with the principles of ICH and Malaysia Good Clinical Practice (GCP), the EC EMEA and Malaysian Note for Guidance on the Investigation of Bioavailability and Bioequivalence. Based on the active metabolite -hydroxy-simvastatin, Zocor^® and Zimmex 40 are proven equivalent in terms of AUC and C_max.

Other bioequivalence studies have been done by various Academic Institutes in Thailand ,namely that of Zensil tablet in May 2002, that of Virogon 800 at the beginning of 2001,and others.