Aurobindo Pharma has received the marketing authorisation approval from UK MHRA (United Kingdom Medicines and Healthcare products Regulatory Agency) for sertraline 50 and 100 mg tablets containing the active ingredient sertraline hydrochloride.
This is the first formulation approval received from UK MHRA for a product developed in house by Aurobindo. With this approval, it will be easier for Aurobindo to obtain similar marketing authorisations for sertraline tablets in the other countries of the European Union through mutual recognition procedure, states a company release.
This generic product is bio-equivalent and has the same therapeutic effect to the innovator product, 'Lustral' of Pfizer Inc.
Aurobindo has already filed 15 products in various EU countries, some of which are nearing the marketing authorization approvals. More filings in the EU countries are in pipeline in the coming years, the release stated.