Last year, US inspectors visit to a facility of Ranbaxy Laboratories Limited and found that a black fibre embedded in a tablet may have been a hair from an employee’s arm. Also ‘black spots’ of oil from machines in tablets and absence of running water in toilets were some observations made by the US Food and Drug Administration (USFDA) that has banned import of drugs made at Ranbaxy’s Mohali unit.
According to USFDA documents sent to Ranbaxy’s Mohali plant head after a series of inspections in 2011 and 2012, the US health regulator made 11 observations citing various violations of current good manufacturing practices (cGMP).
The Mohali plant (in Punjab) is the company’s third plant to come under the USFDA import alert after the Dewas (Madhya Pradesh) and Paonta Sahib (Himachal Pradesh) plants.
Ranbaxy, which is 63.5 percent-owned by Japan’s Daiichi Sankyo Co and gets more than 40 percent of its sales from the United States, did not immediately respond for comment on the FDA observations.
The latest Ranbaxy import ban and a weak rupee may force Daiichi Sankyo to revise down full-year guidance when it announces first half earnings on October 31.
Ranbaxy has lost half its value from its highest level in 2008, when it was first hit by an import ban.