Aurobindo gets marketing approval for mirtazapine tablets in UK
18 Aug 2006
Mumbai: Aurobindo Pharma Limited has received the marketing authorisation approval from the United Kingdom Medicines and Healthcare products Regulatory Agency (UK MHRA) for Mirtazapine 15mg, 30mg and 45mg mg tablets containing the active ingredient mirtazapine.
This is the second formulation approval for an Aurobindo product from UK MHRA. The UK authorisation will make it easier for Aurobindo to obtain similar rights 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 anti-depressant that exhibits both noradrenergic and serotonergic activity.
Mirtazapine enjoys a market of over $140 million in Europe.
Aurobindo 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.
Milpharm, Aurobindos wholly-owned subsidiary, has over 100 market authorisations in Europe.
Aurobindo Pharma Limited, headquartered at Hyderabad, manufactures generic pharmaceuticals and active pharmaceutical ingredients. The company has a robust product portfolio spread over six major therapeutic/product areas encompassing antibiotics, anti-retrovirals, CVS/statins/diabetology, CNS, gastro/uro/kidney therapeutics, anti-fungal/allergics/respiratory, 65 getalactam APIs and 123 non-betalactam APIs.
The company markets its products in over 100 countries. It has filed over 60 ANDAs and 69 DMFs for the USA market, in addition to several filings in other countries. The company has received approvals for several facilities from leading regulatory agencies like the US FDA, UK MHRA, WHO, Health Canada and MCC South Africa.
