Aurobindo Pharma gets USFDA nod for Cefadroxil oral suspension
New Delhi: Drug firm Aurobindo Pharma on Friday said it has received final approval from the US health regulator to manufacture and market generic Cefadroxil oral suspension used for treating bacterial infections in the US market.
The company has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Cefadroxil for oral suspension USP in the strengths of 250mg/5mL and 500mg/5mL, Aurobindo Pharma said in a statement.
The product is the generic equivalent of Warner Chilcott Company Inc's Duricef for oral suspension in the same strengths, it added.
Cefadroxil oral suspension has been approved out of the company's cephalosporin formulations manufacturing facility in Hyderabad, Aurobindo Pharma said.
The company now has a total of 187 abbreviated new drug application (ANDA) approvals (160 final approvals including 4 from Aurolife Pharma LLC and 27 tentative approvals) from USFDA, it added.
Shares of Aurobindo Pharma were trading at Rs 189.40 per scrip on BSE, down 1.04 percent from its previous close.