Aurobindo gets CoS for Domperidone

Aurobindo Pharma, the city-based Rs 1,200-crore bulk drugs major, announced that it had received the first Suitability of Certificate (CoS) from the European Directorate for Quality Medicines (EDQM) for its product Domperidone, an anti-emetic drug that comes under gastroenterology segment.

This will enable the company to export the bulk active to European Union countries. Aurobindo also announced that it had filed Drug Master File (DMF) with US FDA for anti-depressant drug Citalopram.

This is the third DMF filed by the company with US FDA, the other products being Mirtazapine ( also anti-depressant) and Metformin, an anti-diabetic bulk active.

"We have been filing the dossiers with EDQM and US FDA since March 2003. So far, we have filed three DMFs with US FDA and 17 dossiers with either EDQM or specific countries in Europe. Now, our engine is on and we have started getting approvals for our bulk actives. We expect to receive such approvals on regular basis here after," Lanka Srinivas, the director of Aurobindo said.

It may be recalled that the company over the past three years created three API ( Active Pharmaceutical Ingredients, also known as bulk drugs) facilities and four formulation facilities to tap the regulated markets.