US FDA ISSUES ANDA APPROVAL FOR AUROBINDO DIABETES GENERIC

Medium-sized Indian generic drugmaker Aurobindo Pharma has received an abbreviated new drug application (ANDA) approval for its antihyperglycaemic Metformin. The treatment is indicated for Type 2 diabetes and, if granted final approval, will become the company's third product to be cleared for marketing in the US.

Aurobindo claims that its four manufacturing units in India are ready to produce active ingredients for the drug, expected to become a leading volume product for the company. The company filed seven Drug Master Files (DMFs) and five ANDAs in the last quarter, bringing its US and EU filings to 64 DMFs and 15 ANDAs or European equivalents.

However, despite significant new filings in recent months, the company has reported a 70.3% year-on-year decline in net profit for the third quarter of 2004 to INR356.20mn (US$8.12mn). Net sales fell by 1.2% to INR3.19bn (US$73.14mn), but debt service costs increased by 33% in the period, reflecting the company's
recent heavy investment in R&D. In common with many Indian drugmakers, Aurobindo has incurred heavy costs associated with a move into developed markets. The company, which is currently focused on antibiotics, recently acquired a new plant for some INR38mn (US$850,000).