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Our Bureau

Hyderabad , Aug. 9

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

In a press release here, the company said this is the second formulation approval received from the UK MHRA for a product developed in-house. With this approval, the company said it would be easier for it to obtain similar marketing authorisation for Mirtazapine tablets in the other countries of the European Union through Mutual Recognition Procedure.

The company said 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 million in Europe, the company said.

Aurobindo Pharma said it has already filed 20 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.

More Stories on : Standards & Benchmarks | Pharmaceuticals

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