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HYDERABAD: Aurobindo Pharma Ltd (APL) has announced that it has received the marketing authorisation approval from the UK MHRA (United Kingdom Medicines and Healthcare products Regulatory Agency) for Sertraline 50mg and 100mg tablets containing the active ingredient Sertraline Hydrochloride.

APL said this is the first formulation approval received from the UK MHRA for a product developed in-house by the company. With this approval, it would be easier for the company to obtain similar marketing authorisation for Sertraline tablets in the other countries of the European Union through mutual recognition procedure, the company said.

The generic product, Sertraline Hydrochloride, is bio-equivalent and has the same therapeutic effect to the innovator product, Lustral of Pfizer Inc.

The company said it has already filed 15 products in various EU countries, some of which are nearing the marketing authorisation approvals. Many more filings in the EU countries are in pipeline in the coming year, the company said.

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