Financial Daily from THE HINDU group of publications
Tuesday, May 16, 2006
Financial Daily from THE HINDU group of publications Tuesday, May 16, 2006 |
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Corporate
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Regulatory Bodies & Rulings Wockhardt gets USFDA nod for Ceftriaxone Sodium Our Bureau
Mumbai , May 15 Wockhardt Ltd has received the US Food and Drug Administration approval to market Ceftriaxone Sodium injection in the US. The company's US subsidiary Wockhardt USA Inc is expected to launch the broad-spectrum cephalosporin antibiotic in the next few weeks. Ceftriaxone Sodium is the generic or chemically-similar version of Hoffman La Roche's Rocephin injection. "The approval marks Wockhardt's entry into the US injectables market," the Wockhardt Chairman, Mr Habil Khorakiwala, said in a statement. "This is the first out of nine injectables that we have filed with the US FDA. We expect to launch several more products including injectables in the US this year," he added. Ceftriaxone is manufactured at Wockhardt's USFDA-approved sterile cephalosporin bulk-drug facility at Ankleshwar. The formulation or the finished dosage form is manufactured at the dedicated cephalosporin formulation plant at Waluj in Aurangabad, a plant that recently received US FDA approval. The process for the bulk drug and the injection was developed through in-house research, the company said. Ceftriaxone takes up the number of Wockhardt's products in the US market to 12, as compared to five last year. Wockhardt has over 20 products awaiting USFDA approval, the note said. Wockhardt shares closed at Rs 454.75, down 2.15 per cent on the BSE.
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