Aurobindo gets 2nd UK MHRA approval in Mirtazapine Tablets

Aurobindo Pharma Ltd has announced that it has received the marketing authorization approval from UK MHRA (United Kingdom Medicines and Healthcare products Regulatory Agency) for Mirtazapine 15, 30 and 45 mg Tablets containing the active ingredient Mirtazapine.

This is the second formulation approval received from UK MHRA for a product developed in house by the Company. With this approval, it will be easier for the Company to obtain similar marketing authorization for Mirtazapine tablets in the other countries of the European Union through Mutual Recognition Procedure. This generic product is bio-equivalent and has the same therapeutic effect to the innovator product, namely Zispin of Organon Inc.

Mirtazapine is a newer antidepressant that exhibits both noradrenergic and serotonergic activity.

Mirtazapine enjoys a market of over 140 mio Dollars in Europe.

The Company has already filed 20 products in various EU countries, some of which are nearing the marketing authorization approvals. Many more filings in the EU countries are in pipeline in the coming year.

Mill Pharm, the Company´s wholly owned subsidiary has over 100 market Authorizations in Europe.

Source : Equity Bulls

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