Aurobindo Pharma gets USFDA nod for Dexmedetomidine Hydrochloride Injection

The company’s Unit IV manufacturing facility has so far secured 27 ANDA (including two tentative) approvals for manufacturing and marketing general injectable drugs

 The Dollar Business Bureau

Aurobindo Pharma Ltd. on Friday announced that it has earned the US Food & Drug Administration (USFDA) nod to produce and market Dexmedetomidine Hydrochloride injection. This drug is used as a sedation of non-intubated patients who are required to follow surgical or various other types of procedures. The injection will be launched in April-July this year. “The approved ANDA is bioequivalent and therapeutically equivalent to the reference listed drug product (RLD) Precedex Injection, 200 mcg/2 mL, of Hospira, Inc.,” Aurobindo Pharma said in a statement. “The product has an estimated market size of $59.1 million for the twelve months ending January 2016,” the company said. The company’s Unit IV manufacturing facility has so far secured 27 ANDA (including two provisional) approvals for manufacturing and marketing general injectable drugs. With the approval of its current drug, Aurobindo Pharma’s total number of ANDA approval has gone up to 224. The Hyderabad-based drug major continues to expand its presence across the international market. Its manufacturing facilities have received approvals from the world’s leading regulators including ANVISA Brazil, Health Canada, Japan PMDA, MCC South Africa, USFDA, UK MHRA and WHO.   

March 18, 2016 | 05:30pm IST

The Dollar Business Bureau - Mar 18, 2016 12:00 IST
 
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