By IANS
Chennai : Chennai-based pharma major Orchid Chemicals & Pharmaceuticals Ltd (Orchid) Friday announced that it had received approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug applications (ANDA) – Cefdinir capsules (300 mg) and Cefdinir oral suspensions (125 mg/5 ml and 250 mg/5 ml).
Cefdinir is a life-saving cephalosporin antibiotic drug, which became generic only recently. Cephalosporins are drugs that kill bacteria or prevent their growth.
The product had a retail market sale of around $1 billion, prior to the patent expiry in May 2007.
"We are happy that our Cefdinir ANDAs have received the USFDA nod and that both the dosage forms of this product have been approved," K. Raghavendra Rao, Managing Director, Orchid, said here.
"We would be launching this product soon and are confident of achieving a robust market share and revenue profile from this quarter onwards," Rao said.
The Cefdinir generic product range would further reinforce Orchid's leading position in the US cephalosporin market, he said.
"This is indeed a significant approval in our product strategy for the US generics market. The approval from the USFDA has come in a record time frame of a little over 12 months from the filing to approval, reflecting yet again the world-class regulatory compliance standards of the company."