On Friday, the U.S. Food and Drug Administration announced an import alert against one of Ranbaxys Indian manufacturing facilities that was going to produce a generic version of Diovan, a blood-pressure medication made by Novartis.
The FDAs import alert is bad news, for sure, but is that announcement enough to merit such a disaster for the top pharma company in the country? Keep in mind the FDAs move is just the latest embarrassment for Ranbaxy, which this year already has had to pay a huge penalty in an attempt to solve its problems with American regulators. In May, the company admitted it had lied to the FDA about procedures at two of its plants. At the same time, Ranbaxy agreed to pay a $500 million fine to resolve fraud allegations involving improperly manufactured, stored, and tested drugs.
STORY: Buying Prescription Drugs Online Without Getting Burned
Ranbaxy isnt providing much information about the newest punishment. We have so far not received any communication from the U.S. FDA on this subject, Ranbaxy said in an e-mail to Bloomberg News. We are seeking information from the U.S. FDA in this regard.
But the FDAs move does indicate the company has yet to absorb the lesson from its half-billion-dollar fine. It doesnt seem that things have changed, Rohit Bhat told Bloomberg. Everyone knows that the company has been facing FDA compliance issues for their other units, but it was expected that they would have learned from earlier experiences and hoped that they would be able to clear the FDA for this unit.
Ranbaxy isnt the only Indian drugmaker to have problems with the FDA. Another pharmaceutical company, Strides Arcolab (STR:IN), today said in a statement that the U.S. regulator had issued a warning letter after an FDA inspection of its factory in Bangalore.
India's Drugmaking Ambitions Suffer a Big Setback - Businessweek
The FDAs import alert is bad news, for sure, but is that announcement enough to merit such a disaster for the top pharma company in the country? Keep in mind the FDAs move is just the latest embarrassment for Ranbaxy, which this year already has had to pay a huge penalty in an attempt to solve its problems with American regulators. In May, the company admitted it had lied to the FDA about procedures at two of its plants. At the same time, Ranbaxy agreed to pay a $500 million fine to resolve fraud allegations involving improperly manufactured, stored, and tested drugs.
STORY: Buying Prescription Drugs Online Without Getting Burned
Ranbaxy isnt providing much information about the newest punishment. We have so far not received any communication from the U.S. FDA on this subject, Ranbaxy said in an e-mail to Bloomberg News. We are seeking information from the U.S. FDA in this regard.
But the FDAs move does indicate the company has yet to absorb the lesson from its half-billion-dollar fine. It doesnt seem that things have changed, Rohit Bhat told Bloomberg. Everyone knows that the company has been facing FDA compliance issues for their other units, but it was expected that they would have learned from earlier experiences and hoped that they would be able to clear the FDA for this unit.
Ranbaxy isnt the only Indian drugmaker to have problems with the FDA. Another pharmaceutical company, Strides Arcolab (STR:IN), today said in a statement that the U.S. regulator had issued a warning letter after an FDA inspection of its factory in Bangalore.
India's Drugmaking Ambitions Suffer a Big Setback - Businessweek
