Pharmaceutical and biotechnology major Wockhardt Limited today announced US FDA approval to market painkiller tablets containing a combination of Dextropropoxyphene napsylate and Acetaminophen (DPN + APAP) in the US market.
"Wockhardt is the world's largest manufacturer of Dextropropoxyphene and our products based on this drug are sold all over the world," said Wockhardt chairman Habil Khorakiwala. "This is our sixteenth ANDA approval and our first painkiller to be sold in the US."
Dextropropoxyphene combinations are one of the more potent analgesic drugs and is widely used all over the world for control of various kinds of pain.
The US market for the Dextropropoxyphene combination is over $ 100 million 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 US.
The DPN + APAP tablets are manufactured at the US FDA-certified formulation plant at Aurangabad, Maharashtra and the active ingredient is manufactured at the US FDA-approved bulk drug plant at Ankleshwar, Gujarat.
Wockhardt 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.
