Wockhardt gets approval to market painkiller in US

New Delhi, Mar 20: Wockhardt Ltd today said it has received US Food and Drug Administration's approval to market painkiller tablets, containing a combination of Dextropropoxyphene napsylate and Acetaminophen, in the US market.

Dextropropoxyphene combinations (DPN + APAP) are one of the more potent analgesic drugs and is widely used all over the world for control of various kinds of pain.

''This is Wockhart's 16th ANDA approval and our first painkiller to be sold in the US,'' said the company chairman Habil Khorakiwala.

The US market for the Dextropropoxyphene combination is over 100 million dollars and is sold under the brand name Darvocet-N.

Wockhardt USA Inc, the company's wholly-owned subsidiary, will be marketing the painkiller in the United States, a statement said.

The DPN + APAP tablets are manufactured at the US FDA-certified formulation plant at Aurangabad, in Maharashtra, and the active ingredient is manufactured at the US FDA-approved bulk drug plant at Ankleshwar, Gujarat.

The company currently markets 15 products in the US, 10 of which were launched during 2006.

Wockhardt is among the few companies with end-to-end integrated capabilities for its products, starting with manufacture of oral and sterile active ingredients, the dosage forms and marketing through its wholly-owned subsidiary in the US, thus enabling the company to capture maximum value.

UNI