The approval from the US Food and Drug Administration (USFDA) is for Clonidine Hcl injections of strength 0.1mg/ml, 0.5mg/ml and 10mg/ml the company said in a filing to the BSE.
The injection is used in treatment of severe pain in cancer patients that is not adequately relieved by opioid analgesics alone.
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The company has now 90 approvals and has so far filed 216 abbreviated new drug applications since the filing process began in 2003-04, it added.
Shares of the company closed 4.69 per cent higher at Rs 995.10 apiece on the BSE today.