Auriga Research Limited, the CRO subsidiary of Arbro Pharmaceuticals Ltd based in Delhi, has got the approval for conducting bioavailability and bioequivalence studies for new drug formulations.
The company has already launched five bioavailability and bioequivalence studies for national and international clients and has set up a dedicated clinical pharmacology and pharmacokinetics unit for the purpose. The approval for the BA and BE studies was given by the DCGI recently.
``We are also in talks with a number of clients to further consolidate the business on the clinical trials front. There are at present only a couple of CROs in the entire North India and we see a great potential in this area,'' its chairman Vijay Arora said.
Auriga Research Ltd is the third venture from the established group which already has Arbro Pharmaceuticals Ltd. and Arbro analytical division. The analytical division would be brought under the brand of Auriga Research soon and the company is planning to develop a bigger facility to house the clinical trial operations and analytical services.
Arbro Pharmaceuticals Ltd. is also into an expansion mode, developing PCR-based diagnostic kits for diseases like TB, Hepatitis B and cancer, in association with leading educational institutions. It has also submitted a project to the Biotechnology Department for development of kits.
ARL conducts BA and BE studies during the development period and for regulatory submission. This includes BE studies intended for submission in ANDA and BE studies conducted in the post approval period for certain changes in both NDA and ANDA.
"Its clinical pharmacology unit has been designed to provide the subjects the utmost safety, hygiene and comfort while offering a systematic flow for conduct of BA and BE studies. There is a fully equipped ICU for handling potential emergencies that may occur during the trials. The bio-analytical laboratory is equipped with state-of-the-art equipments,'' said Arora.