Orchid Chemicals & Pharmaceuticals Ltd., the Chennai-based pharma major, has filed its seventh Abbreviated New Drug Application (ANDAs) with the US FDA. These seven ANDAs cover various finished dosage forms of three cephalosporin antibiotic products, including two sterile products and one oral product. The combined current retail market of these 3 products in the US is estimated at over US$ 1 billion.
The company said its ANDAs are filed from the state-of-the-art oral and sterile cephalosporin formulation facilities at Irungattukottai, near Chennai. The plant is designed for USFDA compliance standards and is expected to go in for US FDA inspection once the regulatory agency reviews the ANDAs submitted.
Commenting on the ANDA filings, Orchid's managing director K Raghavendra Rao stated that Orchid has the most comprehensive end-to-end connected business strategy for the regulated markets in the challenging cephalosporin antibiotic space. The accelerating pace of DMF and ANDA filings would support the overall corporate objective of gaining a significant share in this lucrative market space.
Orchid has exclusive marketing arrangements with Apotex and Par Pharmaceuticals of USA to market Orchid's sterile and oral cephalosporin formulations respectively in the US. The marketing alliance with Apotex has also been extended to the Canadian market. To propel its entry and growth in the US generics market, Orchid has identified 15 key antibiotic products, including key high-margin products that are scheduled to go off patent progressively between 2005 and 2008. The ANDA filings are set to continue on fast track during the coming quarters as well, said sources.