Zydus gets USFDA final nod to market anti-diabetic drug

Last Updated: Thu, Feb 14, 2013 22:11 hrs

Ahmedabad-based drug major Cadila Healthcare Limited, also known as Zydus Cadila, has received US Food and Drug Administration's (USFDA) final approval to market Pioglitazone HCI tablets in US.

The drug, which falls in the anti-diabetics segment, will be marketed in different strengths of 15 mg, 30 mg and 45 mg. "The estimated sales in 2012 for Pioglitazone HCI tablets is USD 2 billion," the company said in a statement on Thursday. It may be mentioned here that in September 2012 the company had received the US drug regulator's nod to market Irbesartan tablets, an anti-hypertension drug, in the US market in strengths of 75 mg, 150 mg and 300 mg. Earlier in 2012, Cadila Healthcare's US subsidiary Zydus Pharma USA Inc had also received USFDA approval to sell oral tablets of Ultracet (Acetaminophen ;Tradamadol hydrochloride) in the US.

The company had also closed a definitive agreement regarding re-launch of Kinlytic (urokinase) in North American markets with Canada-based biotechnology player Microbix Biosystems Inc in August last year.

The group now has 75 approvals and has so far filed 170 ANDAs since the commencement of filing process in financial year 2003-04.

While global business accounts for nearly 50 per cent of the company's 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.

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