Aurobindo Pharma manufactures anesthetic injections in US

Bupivacaine Hydrochloride Injection may be launched in the second quarter of FY2016-17.

The Dollar Business Bureau

India-based pharmaceutical manufacturing company, Aurobindo pharma has got approval from the US food and drug administration (USFDA) to produce and market its anaesthetic Bupivacaine Hydrochloride injection in the American market. 

The company would manufacture Bupivacaine Hydrochloride Injection USP-0.25% (2.5 mg/mL) and 0.5% (5 mg/mL) 50 mL multiple dose vials.

This injection could possibly be launched in the second quarter of FY2016-17.

Aurobindo pharma recently mentioned that the sanctioned ANDA is a generic version of Hospira Inc's Marcaine injection. The product’s market size is around $5.6 million for 12 months ended March 2016.

“Bupivacaine Hydrochloride injection is used in the production of local or regional anaesthesia or analgesia for surgery, diagnostic and therapeutic procedures, and for obstetrical procedures, the pharma company said.  

USFDA has approved 262 ANDA- 224 final approvals containing 11 from Aurolife pharma LLC and 38 tentative approvals. 

In March 2016, the pharma company, Aurobindo received a nod from the US health regulator to manufacture and market pantoprazole sodium for injections, used in the treatment of gastroesophageal reflux disease in the American market.


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The Dollar Business Bureau - May 17, 2016 12:00 IST