Aurobindo Pharma on Thursday said it has received final approval from US Food and Drugs Administration to manufacture and market Nafcillin for Injection packaged in 1g and 2g vials and Nafcillin for Injection in 10g/vial pharmacy bulk package.
Nafcillin is an antibiotic in the penicillin group of drugs and is indicated in the treatment of infections caused by staphylococci bacteria.
These ANDAs have been approved out of Unit XII formulation facility in Hyderabad and will be marketed and sold by US subsidiary AuroMedics Pharma LLC, Aurobindo said.
The company now has 171 ANDA approvals, including 26 tentative approvals from US FDA.
On Monday, It had announced US FDA approval to manufacture and market Ondansetron Injection 2mg/ml strength packaged in 40mg/20ml multiple dose vials and 4mg/2ml single dose vials. It is indicated for prevention of nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy or post-operative nauses and or vomiting.
Aurobindo Pharma shares were up 0.4 percent at Rs 194 on NSE in morning trade.
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