Aurobindo receives USFDA approval for Ranitidine syrup

NEW DELHI: Aurobindo Pharma today said it has received approval from the US Food and Drug Administration ( USFDA) to sell generic ulcer medicine ranitidine syrup in the US market.

The final approval is for oral solution of 15 mg per ml, the company said in a statement.

Ranitidine syrup is the generic equivelent of GlaxoSmithKline's 'Zantac' syrup. It is used in the treatment for active duodenal ulcer, benign gastric ulcer and erosive esophagitis.

Quoting IMS data, the company said the medicine has a market size of approximately 40 million dollars.

Aurobindo now has a total of 121 abbreviated new drug applications (ANDA), out of which 91 are final approvals and 30 are tentative approvals from the USFDA, it added.

The company's scrips were trading at Rs 982 per share in the morning trade, up 0.84 per cent from the previous close.