Ranbaxy raided by US officials
subjected to a search by federal officials the company reported
last week.
A spokesperson for the firm told In-PharmaTechnologist.com that despite the search, no facilities or offices have been closed and operations continue as normal. "This action has come as a surprise," a statement from the company read. "The company is not aware of any wrongdoing. It is co-operating fully with the officials." Speculation has been rife since the news broke last week, but Mr Raghu Kochar of Ranbaxy was unable to disclose any information regarding the reasons for the search, or indeed which agency was responsible. Media reports have suggested that documents were seized from the New Jersey offices, and the most likely candidate for carrying out the search is the US Food ad Drug Administration (FDA). Generics manufacturer Ranbaxy has been quiet on the matter since it released a statement last Wednesday, and the FDA is also refusing to comment. Ranbaxy's US subsidiary, Ranbaxy Pharmaceuticals, established operations in the country in 1994, and began marketing abbreviated new drug application (ANDA) approved generic products in 1998 following FDA approval of cefaclor. The US arm's manufacturing capacity is through its subsidiary, OHM Laboratories, also based in Princeton, New Jersey. The company only earlier this month announced that it had received final FDA approval to manufacture and market sertraline hydrochloride tablets, a generic version of Pfizer's blockbuster Zoloft (sertraline hydrochloride) which lost patent protection last year, as well as sertraline hydrochloride oral concentrate. Annual market sales for sertraline hydrochloride tablets are around $3.07bn (€2.34bn), and $4.8bn for the oral concentrate, according to the company, and sales of the drug are set to boost Ranbaxy's already impressive 15 per cent share in the US generics market. Ranbaxy represents one of the growing Indian pharmaceutical players who are slowly but surely encroaching on territory traditionally the ground of big US and European pharmaceutical companies. Along with Dr Reddy's and Nicholas Piramal among others, Ranbaxy is one of the Indian firms becoming more prominent on the pharmaceutical industry playing field. It seems though that of these Indian-based generics firms, Ranbaxy is not the only one to receive recent regulatory scrutiny. It has been reported in the Indian press that Wockhardt is also now the subject of a domestic regulatory investigation. According to several Indian news reports, the Maharashtra Food and Drug Administration (FDA) has cancelled the firm's licence for its human recombinant insulin mixture, Wosulin 50:50 after it was found that the product contained 100 per cent clear solution instead of 50 per cent clear solution and 50 per cent suspension. Neither the Maharashtra FDA or Wockhardt were available for comment, so these reports remain as yet unconfirmed.
