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Aurobindo gets 2nd UK MHRA approval |
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09 Aug 2006 |
Announce 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.
HYDERABAD, India | Aug 09, 2006 | Aurobindo Pharma Limited (Reuters Code: ARBN.BO) is pleased to announce 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 Aurobindo. With this approval, it will be easier for Aurobindo 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. Aurobindo 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, Aurobindo’s wholly owned subsidiary has over 100 market Authorizations in Europe.
About Aurobindo Pharma Limited:
Aurobindo Pharma Limited (www.aurobindo.com), headquartered at Hyderabad, India, manufactures generic pharmaceuticals and active pharmaceutical ingredients. The company’s robust product portfolio is spread over 6 major therapeutic/product areas encompassing (Antibiotics, Anti-Retrovirals, CVS/ Statins/Diabetology, CNS, Gastro/Uro/Kidney therapeutics, Anti fungal/ allergics/respiratory) around 65 Betalactam APIs and 123 Non-Betalactam APIs.
The Company markets its products in over 100 countries. The company has filed over 62 ANDAs and 67 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 US FDA, UK MHRA, WHO, Health Canada, MCC South Africa.
For further information, please contact:
Investor Relations
Aurobindo Pharma Limited
Plot # 2, Maitri Vihar | Ameerpet
Hyderabad - 500 038 |India
Phone (Board): +91 40 6672 5000 |
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SOURCE: Aurobindo Pharma Limited |
