As recognition to its Quality Management System, Aristopharma achieved ISO 9001:2000 certificate in 2005. The certificate was issued by Orion Registrar Inc. USA, one of the prime certification bodies in the world. The certificate covers the principal office, the factory, all the sales depots including the central warehouse. Later on the certificate was upgraded to ISO 9001:2008 standard.
Clinical trials are health related research studies that are conducted to evaluate efficacy & safety data of a drug. Hence, conducting clinical trial in Bangladesh is important in the eyes of health professionals because it is always better to depend on results of clinical trial on Bangladeshi people than on foreign people. Aristopharma took pioneering role in conducting such trial. First time in Bangladesh it opened a special department named Clinical Research & Medical Services Department (CRMSD) to conduct clinical trials with its products upon Bangladeshi people. Some clinical trials are already done and some are ongoing.
Bioequivalence study is done to evaluate whether a drug is similar to the research brand in terms of rate & extent of absorption in the body. It involves the analysis of various pharmacokinetic properties like Cmax, tmax, t1/2, AUC of the products. If these properties of the tested brand are found similar to those of the research brand, the tested brand is called bioequivalent to the research brand, and hence they are considered interchangeable.
Aristopharma became the first company to carry out bioequivalence study on its Omeprazole brand, Omep in 2008. The study was conducted at Department of Clinical Pharmacy & Pharmacology of University of Dhaka under the supervision of Prof. Abul Hasnat. The bioequivalence study showed that Omep has similar bioavailability like the research brand of Astra Zeneca. Therefore, anyone taking Omep will get all the benefits of the higher priced research brand. The detail of the study was published in the April 2009 issue of the German medical journal Arzneimittelforchung (Drug Research).
In 2009 Aristopharma conducted bioequivalence study on its Trimetazidine brand, Metacard MR Tablet under the same Professor in University of Dhaka. The company also conducted bioequivalence study for its Lodipin-5 (Amlodipine) Tablet, AZ (Azithromycin) Suspension & Capsule and Aropen (Meropenem) Injection.
These bioequivalence reports have already been accepted by the regulatory bodies of several countries and thus are helping in our export.
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