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Wockhardt gets US FDA nod for zolpidem in US
Our Bureau, Mumbai | Monday, May 21, 2007, 08:00 Hrs  [IST]

Wockhardt Ltd has received US FDA approval for marketing zolpidem tablets in the US. Zolpidem tablet is one of the most widely used medicines to treat insomnia (sleep disorder) and is safer than most other sleeping pills in replicating normal sleep patterns. Zolpidem, which is the generic name for the brand Ambien, sold by sanofi-aventis constitutes a market of about $2.2 billion in the US.

"The key to our success in the competitive US market is our ability to continuously add to the breadth and depth of our product portfolio," said the company chairman Habil Khorakiwala. "With our strategic thrust, we are advancing in the US market at an accelerated pace, rightly established by the fact that zolpidem is our twentieth product to be launched in the US market in addition to Wockhardt having received six US FDA approvals in the last two months alone."

The company manufactures zolpidem tartrate API at its US FDA approved facility at Ankleshwar, Gujarat while the tablets are manufactured at the US FDA certified formulation plant at Waluj, Maharashtra.

The company's US subsidiary, Wockhardt USA Inc. has been consistently increasing its market share in all products. Apart from zolpidem, the company markets 19 products in the US; of which three injectables viz, Ketorolac, Furosemide and new strengths of Ceftriaxone were launched in the last four weeks alone. Very soon, the company will also be launching Lisinopril tablets in the US market.

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