Orchid receives US FDA approval for its Cefdinir ANDAs

Orchid Chemicals & Pharmaceuticals Ltd on July 20, 2007 has announced that it has received approval from the US FDA for its ANDAs (Abbreviated New Drug Application) for Cefdinir for 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 only 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 the Company'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 a little over 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 Mr. K Raghavendra Rao, Managing Director.

The stock was trading at Rs.242.70, down by Rs.0.95 or 0.39%. The stock hit an intraday high of Rs.248.75 and low of Rs.241.10. The total traded quantity was 90049 compared to 2 week average of 76231.

Source : Equity Bulls

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