Financial Daily from THE HINDU group of publications
Tuesday, Jul 06, 2004
Financial Daily from THE HINDU group of publications Tuesday, Jul 06, 2004 |
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Corporate
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Standards & Benchmarks Six Wockhardt units get USFDA approval Our Bureau
Mumbai , July 5 The Mumbai-based drug company, Wockhardt Ltd, has got the US regulatory approval for six of its manufacturing plants at Aurangabad, Waluj and Ankleshwar. Company officials told Business Line that this would strengthen it's aggressive plans in the US, the world's largest generic drugs market. The US Food and Drug Administration (USFDA) has approved Wockhardt's sterile injectable facility as well as its facilities for sterile bulk drugs (active pharmaceutical ingredient) and formulations, according to a company communiqué . In addition to visiting Wockhardt's manufacturing units, the US FDA team also reviewed the company's progress in abbreviated new drug applications (ANDA), the note said, and added that more approvals were expected soon. The company recently established Wockhardt USA Inc, a sales and marketing subsidiary in the US. It has ambitious plans in the US, and has so far applied for 17 ANDAs, of which the US FDA has approved nine. Wockhardt expects to apply for 15 ANDAs this year. It has filed 32 DMF (drug master file) applications to export active pharmaceutical ingredients to the US. The company's US plans are supported by about 150 professionals at Wockhardtin India.
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