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Aurobindo Pharma has got the US health regulator’s final approval for manufacturing and marketing its anaesthetic Bupivacaine Hydrochloride injection in the American market.
Aurobindo Pharma has said in a BSE filing that the company “has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Bupivacaine Hydrochloride injection USP, 0.25 percent (2.5 mg/mL) and 0.5 percent (5mg/mL) 50 mL multiple dose vials.”
It further said that this product is expected to be launched in the second quarter of 2016-17 fiscal.
“The approved product has an estimated market size of USD 5.6 million for the twelve months ended March 2016, according to IMS.”
