Company Watch

Orchid receives USFDA nod for Cefprozil tablets

Our News Bureau - Chennai

The Chennai-based pharma major, Orchid Chemicals & Pharmaceuticals announced that it has received the formal approval from the USFDA for its ANDA for Cefprozil tablets USP, 250 mg and 500 mg. The current US market size for Cefprozil tablets is $117 million.

Orchid will launch the product exclusively through Par Pharmaceuticals immediately upon the expiry of the patent on December 23, 2005. This is the eighth cephalosporin ANDA approval that Orchid has received till date covering four cephalosporin products in various dosage forms. Orchid expects more ANDA approvals to follow in the months to come. As of date, Orchid has filed 21 ANDAs with USFDA.

"This is an important approval in our regulated markets strategy. We are happy that we have received the approval in time to launch the product immediately after the patent expiry on December 23, 2005. We expect Cefprozil to be a lead product in the distribution alliance with Par Pharmaceuticals in the US generics market and are confident of capturing a sizeable share of the oral cephalosporin generic formulations market going forward," said K Raghavendra Rao, Managing Director, Orchid Chemicals & Pharmaceuticals.