Hyderabad- based Aurobindo Pharma received its first Certificate Of Suitability (COS) approval from the European Directorate of Quality Medicines (EDQM) for its product in the therapeutic segment of gastroenterology.
The company has also filed two DMFs with the US FDA making the total number of filings with US FDA to three (two in CNS and one in diabetology). The recent one was for Citalopram, an antidepressant and the file number is 16850.
The company’s new infrastructure for regulated markets, three API facilities (Unit 1, Unit 6 and Unit 8) comprising over 15 blocks and four formulation facilities (Unit 3, Unit 6, Unit 12 and its joint venture unit at Pomona, Los Angeles) comprising 15 formulation modules, built up during the restructuring phase, enables the company to file COS/DMFs/ANDAs in the US and European Union pharma markets at a rapid pace. The company has so far filed over 20 such dossiers.
By the virtue of COS, Aurobindo will be able to gain entry into the European Union pharma market. The company expects to receive such approvals on a routine basis in the future.