Aurobindo gets 2nd UK MHRA nod for Mirtazapine Tablets
Mumbai, Aug 9 (UNI) Pharma major Aurobindo Pharma Ltd has received marketing authorisation 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.
Announcing this to BSE today, the company said this was the second formulation approval received from UK MHRA for a product developed in-house by the company. With this approval, it would be easier for the company to get similar marketing authorisation 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, which is a newer anti-depressant that exhibits both noradrenergic and serotonergic activity, enjoys a market of over 140 million dollars in Europe.
The company 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 years. Mill Pharm, the company's wholly owned subsidiary, has over 100 market authorizations in Europe.
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