Aurobindo Pharma has secured approval from the US FDA to manufacture and market nafcillin for injection USP, packed in 1g and 2g bottles as well as nafcillin for injection USP 10g bottle pharmacy bulk package.
Nafcillin, is a sterile semisynthetic penicillin to treat infections caused by penicillinase producing staphylococci, which have shown susceptibility to the drug.
The injection may also be used for treatment in doubtful cases of resistant staphylococcal infections before receiving the susceptibility test results.
The USFDA approved nafcillin injections have been manufactured in unit XII formulation facility, Hyderabad, India, which will be marketed and sold by Aurobindo's US subsidiary AuroMedics Pharma.
The approved products are ready for launch,according to the company.
Aurobindo presently has 171 ANDA approvals, which include 145 final approvals and 26 tentative approvals from USFDA.
Out of the total 145 approvals, two approvals come from US-based Aurolife Pharma, part of Aurobindo group of companies.
Aurobindo Pharma manufactures generic pharmaceuticals and active pharmaceutical ingredients for six areas, which include antibiotics, anti-retrovirals, CVS, CNS, gastroenterologicals and anti-allergics.
