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Published on 10/31/2005 in the Prospect News Biotech Daily.

Aurobindo receives U.K. approval for Sertraline

New York, Oct. 31 - Aurobindo Pharma Ltd. said it received marketing approval from the United Kingdom Medicines and Healthcare products Regulatory Agency for Sertraline 50 and 100 mg tablets containing the active ingredient Sertraline Hydrochloride.

The approval is the first from the agency for a product developed in house by Aurobindo.

Under the mutual recognition procedure, it will be easier for Aurobindo to receive similar authorization for Sertraline elsewhere in the European Union.

Sertraline is a generic product bio-equivalent to Lustral of Pfizer Inc.

Aurobindo Pharma is a Hyderabad, Andhra Pradesh, India, maker of generic pharmaceuticals and pharmaceutical ingredients.


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