Aurobindo Pharma gets US approval to sell generic Omnicef
19 Dec 2007
Mumbai: Aurobindo Pharma Ltd has won regulatory approval to sell its cefdinir oral suspension, a generic version of Abbott Laboratories' antibiotic Omnicef, in the US.
The US Food and Drug Administration said in its website that it has allowed Hyderabad-based Aurobindo Pharma to sell the generic drug, which is used to treat ear, sinus, throat and skin infections.
Omnicef generated $637 million in sales last year for Abbott Park, Illinois-based Abbott.
Aurobindo Pharma, which has plans to emerge as a billion dollar company by 2009-10, is enhancing its presence in Europe by investing $100 million in phases.
The company is likely to buy two pharma companies worth Euro 10 million each, open offices in 10 countries and establish a packaging, warehouse and manufacturing hub in Malta.
Aurobindo also may make strategic investments worth $10 million in the Gulf Cooperation Council (GCC) countries.
It is also setting up an active pharmaceutical ingredients (API) manufacturing plant at Annapolis in Brazil investing around $8 million.
Aurobindo already has a manufacturing unit in New Jersey, in the US.
With over 117 filings to its credit, the company has emerged as a leader in filing drug master files (DMF) for APIs in the US. The company has filed over 107 abbreviated new drug applications (ANDAs) in the US.