Unichem gets USFDA nod to commercialise Amiodarone tablets

The shares of Unichem Laboratories surged almost 3 per cent from its day’s low on Wednesday after the company announced that it has received abbreviated new drug application (ANDA) approval from United States Food and Drug Administration (USFDA) to market its Amiodarone tablets, USP, 200 mg.

Amiodarone tablets are the generic version of Cordarone (Amiodarone) tablets of Wyeth Pharmaceuticals Inc.  

The drugs are indicated for the treatment of documented, life-threatening recurrent ventricular fibrillation and life-threatening recurrent hemodynamically unstable tachycardia in adults, who have not responded to adequate doses of other available antiarrhythmics.

The product will be commercialised from Unichem’s Ghaziabad Plant, the company stated in a press release to BSE.

Unichem Laboratories Limited is a pharmaceutical company manufacturing active pharmaceutical ingredients (APIs) or bulk actives. In addition, it has various pharma products for addressing therapeutic areas, such as gastroenterology, cardiology, diabetology, psychiatry, neurology, antibacterials, anti-infectives, and pain management.

At 1 pm on Wednesday, the stock of Unichem Laboratories was trading at Rs 213.3, higher by 1.35 per cent or Rs 2.85 per share on the BSE, against a 0.20 per cent loss in the benchmark index.