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NT Bureau
Chennai, July 23:
Chennai-based pharma major, Orchid Chemicals & Pharmaceut-icals Ltd 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 Suspen-sion 125 mg/5 ml and 250 mg/5 ml.
Cefdinir is a life saving cephalos-porin antibiotic drug which became generic only recently. The product had a retail market sale of around $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 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 K Raghavendra Rao, managing director.