Aurobindo Pharma has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Cefadroxil for Oral Suspension USP 250mg/5mL and 500mg/5mL.
Cefadroxil for Oral Suspension USP, 250mg/5mL and 500mg/5mL is the generic equivalents of Warner Chilcott Company, Inc’s Duricef for Oral Suspension 250mg/5mL and 500mg/5mL. Cefadroxil is a cephalosporin antibiotic indicated for the treatment of patients with infection caused by susceptible strains of the designated organisms such as urinary tract infections caused by E.coli, P.mirabilis, and Klebsiella species; skin and skin structure infections caused by staphylococci and/or streptococci; Pharyngitis and/or tonsillitis caused by Streptococcus pyogenes.
The product has been approved out of Unit VI Cephalosporin formulations manufacturing facility in Hyderabad, India. The company now has a total of 187 ANDA approvals (160 Final approvals including 4 from Aurolife Pharma LLC and 27 Tentative approvals) from USFDA.
Aurobindo Pharma manufactures generic pharmaceuticals and active pharmaceutical ingredients. The company’s robust product portfolio is spread over 6 major therapeutic/product areas encompassing Antibiotics, Anti-Retrovirals, CVS, CNS, Gastroenterologicals, and Anti-Allergics, supported by an outstanding R&D set-up.
