Orchid Chemicals & Pharmaceuticals today announced that it has received approval from the USFDA for its abbreviated new drug application (ANDA) of cephalexin capsules - USP 250 mg and 500 mg. According to a release issued to the BSE today, this is the first ANDA approval received in the oral formulations segment in the US by the company."Cephalexin is an off-patent molecule that forms part of Orchid's distribution alliance with US generic pharma major Par Pharmaceuticals," the release added.K Raghavendra Rao, managing director of Orchid, said: "The USFDA approval for cephalexin capsules will give a good start to our generic, oral formulations marketing in the US. We hope to launch the product in shortly, and are confident that our distribution partner (Par Pharma) will be able to achieve good market presence."Orchid had earlier received ANDA approval from the USFDA for its sterile injectable generic product cefazolin, the release said.
