Zydus gets USFDA nod for Ultracet painkiller

The company's shares touched a 52-week high at the BSE at Rs 938 in intra-day trade

Ahmedabad based pharma major Cadila Healthcare (Zydus) has received the US drug regulator's nod to market a generic painkiller under the name Ultracet. The company's shares touched a 52-week high at the Bombay Stock Exchange (BSE) at Rs 938 in intra-day trade.

Cadila Healthcare's US subsidiary Zydus Pharma USA Inc received the US Food and Drug Administration's (USFDA) nod to market oral tablets of

Ultracet (Acetaminophen ;Tradamadol hydrochloride) in the US in strengths of 325 mg and 37.5 mg, said a notice on the FDA website.

Sources in Zydus informed that global business accounts for nearly 50 per cent of its revenues, and US contributes a substantial portion. It is estimated that US operations contribute to over 25 per cent of the company's net sales.

 

The company has recently received a tentative approval from the US FDA for Aripiprazole orally disintegrating tablets in the strengths of 10 mg, 15 mg, 20 mg and 30 mg in August. The drug is an anti-psychotic medication used in the treatment of schizophrenia.

During August, the Ahmedabad based company also closed a definitive agreement regarding re-launch of Kinlytic (urokinase) in North American markets with Canada based biotechnology player Microbix Biosystems Inc. Urokinase is used in clearing pulmonary embolisms and intravenous catheter blockages, and has been administered to over four million patients since it was first approved in the US in 1978. Under the agreement, Microbix has licensed to Zydus Cadila all its rights and expertise relating to urokinase.

Zydus' consolidated revenue figures touched Rs 5263.31 crore during the 2011-12 financial year, up from Rs 4630.59 crore in the previous fiscal.

Earlier, the company's shares had touched a 52-week high on August 7 at Rs 925.9 after news of the USFDA revoking the warning letter issued to Zydus' Moraiya facility came in.