Although Ranbaxy has ruled out any possible impact on its US operations owing to the recent federal investigations, the company is likely to be hurt if the US Food and Drug Administration (FDA), the medical regulatory authority in the US, asks it to re-submit the abbreviated new drug applications (ANDA) for generic drugs which are awaiting approvals in the US. The North American business, covering the US and Canada, constitute around 26% of Ranbaxy?s global revenues.
According to experts, Ranbaxy will have to re-submit the data for the pending ANDAs if the USFDA raises any concerns over the submitted data. In its presentation detailing the reasons behind the recent Ranbaxy buyout, Japanese firm Daiichi-Sankyo had said, ?There are 18 ANDAs where Ranbaxy has first to file (FTF) status that could potentially give it a 180-day marketing exclusivity for drugs with $27 billion sales revenues. Major products where Ranbaxy has already negotiated settlements securing the right to launch with a 180-day marketing exclusivity, such as sumatriptan and valcyclovir, with innovators? sales, comes to about $8 billion.?
As on December 2007, Ranbaxy made cumulative filings of 239 ANDAs with a total of 141 approvals. The company made 28 ANDA filings during the year and received 18 approvals from the
USFDA. Ranjit Kapadia, head of research of PCG, Prabhudas Lilladher, said, ?Though Ranbaxy has submitted the data, the USFDA can ask to re-submit the data for pending ANDAs if they found any manipulations in the data. They can ask the company to rectify the anomalies related to the FDA approved manufacturing plants, which will hit the company?s export to the US.? In 2005, the US-based Able Labs had stopped manufacturing and recalled all of its products, after a concerned FDA raised questions over quality control data used to get marketing approval for its products in the US. Declining Able?s proposal for re-validating the data, FDA had said it had to withdraw and resubmit ANDAs with new data, which was a lengthy and costly process that the company could not afford. A Ranbaxy spokesperson told FE,?Ranbaxy stands behind its USA ANDAs. There is no reason for any resubmission nor has this ever been suggested. We will continue to file ANDAs and remain committed to selling affordable generic products in the US.?
Mark Pohl, a US-based registered patent attorney says, ?When the FDA finds falsified or misleadingly incomplete documents submitted by generic firms, the company can be debarred, with which the FDA will refuse to do business with the company. Thus the company can?t get new ANDAs approved and can?t maintain existing ANDAs. Thus, when the FDA debars a company, the company is effectively out of business.?
