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.

First company in Bangladesh to conduct clinical trial

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 a 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.

1. The first clinical trial was carried out with its Cefpodoxime brand, Taxetil and Cefixime brand, Afix. The study was conducted from March 2003 to August 2004 at Dhaka Shishu Hospital under the guidance of renowned pediatrician Prof. Md. Salim Shakur. The study showed that both Taxetil & Afix are highly effective in the treatment of enteric fever of children. The study report was published in November 2007 issue of Indian Pediatrics.
2. In 2008-2009 the company conducted research on "Role of Trimetazidine (Metacard MR) in the prevention of contrast induced nephropathy after coronary angiogram & percutaneous coronary intervention (PCI)" at Bangabandhu Sheikh Mujib Medical Uinversity (BSMMU) under the guidance of Prof. Sirajul Haque. Research proved that Metacard MR significantly reduces the risk of contrast-induced nephropathy. The study report was published in Mymensingh Medical Journal (MMJ) in April 2012.
3. Aristopharma actively participated in the clinical trial entitled “A Comparison of the Clinical Impact of Enoxaparin-induced Bleeding Measured by two Different Classifications among Patient with Acute Coronary Syndrome”. The study was conducted at Department of Cardiology, Bangabandhu Sheikh Mujib Medical University (BSMMU), Dhaka during October 2011 to March 2012. The study report was published in University Heart Journal Vol. 8, No. 2, July 2012.
4. The company has participated in a study titled "Modulation of Insulin Secretion and Insulin Sensitivity in Bangladeshi Type 2 Diabetic Subjects by an Insulin Sensitizer Pioglitazone and its Pharmacokinetic Study" conducted in the Faculty of Pharmacy of university of Dhaka under the guidance of renowned scientist Prof. A. K. Azad Chowdhury.
5. The company has conducted clinical trial entitled “Iron Polymaltose Complex in the Treatment of Iron Deficiency Anemia in Pregnancy”. The trial was conducted at OPD of Bangladesh Medical College and two other clinics of Dhaka city during August 2011 to September 2013. The trial report was published in Mymensingh Medical Journal in 2016.

First company to conduct Bioequivalence Study in Bangladesh

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.

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.