The Chennai-based pharma major, Orchid Chemicals and Pharmaceuticals Ltd (Orchid) has received approval from the US FDA for its Abbreviated New Drug Application (ANDAs) for Cefdinir capsules 300 mg and Cefdinir for oral suspension 125 mg/5 ml and 250 mg/5 ml.

Cefdinir is a life saving cephalosporin antibiotic drug, which became generic recently. The product had a retail market sale of around USD 1 Billion prior to patent expiry in May 2007. The cefdinir generic product range would further reinforce Orchid's leading position in the US cephalosporin generics market.

"We are happy that our Cefdinir ANDAs have received the US FDA nod and that both the dosage forms of this product have been approved. This is indeed a significant approval in our product strategy for the US generics market. The approval from the US FDA has come in a record time frame of 12 months from filing to approval, reflecting yet again the world-class regulatory compliance standards of the company. We would be launching this product soon and are confident of achieving a robust market share and revenue profile from this quarter onwards", said K Raghavendra Rao, managing director.