Ranbaxy Laboratories, India`s largest drugmaker has requested the US drug regulator, Food and Drug Administration (USFDA), to re-inspect its manufacturing plant at Dewas, Madhya Pradesh, raising hopes of an early resolution to its ongoing regulatory issues with the American drug regulator, reports Economic Times.
In September 2008, the USFDA, issued warning letters to Ranbaxy (Q,N,C,F)* for not adhering to the US manufacturing standards at its plants in Dewas and Paonta Sahib, Himachal Pradesh from where drugs were made and exported to the US. It also banned 30 drugs made by the Gurgaon-based company at these two plants and halted approval of new drug applications.
Industry analysts said the re-inspection follows a recent meeting of the company management with the USFDA and an inspection may happen by the end of the year. A subsequent approval means Ranbaxy can launch new drugs from the plant, and start re-supplying those drugs to the US which are now banned by FDA.
A Ranbaxy spokesman said, ``We cannot comment on specific meetings. We have been, are, and will be in close communications with the agency. For Dewas, we have invited the FDA for the facility`s re-inspection. However, we would not speculate when they would visit us.``
Shares of the company gained Rs 5.15, or 1.61%, to trade at Rs 325. The total volume of shares traded was 74,604 at the BSE (11.09 a.m., Friday).