Pharmaceutical and biotechnology major Wockhardt Limited announced US FDA approval for marketing Ketorolac anti-inflammatory injection in the US market, its third US FDA approval in the last ten days.
"Our US business is a fast track with two more injectables to be launched in the next few days - Furosemide and Ketorolac," Wockhardt chairman Habil Khorakiwala said. "This is our fifth injection product in the US market. Ketorolac in particular is a complex product to develop and manufacture and its approval is a reflection of our mastery over technology and regulatory compliance."
Ketorolac is a potent non-steroidal anti-inflammatory drug used in the management of acute pain following surgery and trauma. Over 40 million vials of Ketorolac injections, valued at $36 million, are consumed annually by hospitals across United States, as per IMS. There are only few players because of US FDA's stringent regulatory process for approval of sterile injectables.
Wockhardt's wholly-owned subsidiary Wockhardt USA Inc will be marketing Ketorolac injection directly to hospitals, wholesalers, doctor clinics and managed care companies.
The injections are manufactured at the US FDA-certified sterile formulation plant at Waluj, Maharashtra.
Wockhardt currently markets 15 products in the US, with two more to be launched soon. As the development and manufacture of the dosage forms and marketing are all undertaken in-house, Wockhardt is able to capture maximum value from its products sold in the US market.
