Ranbaxy, the international Drug Manufacturer admitted in the United States to charges of making and distributing adulterated drugs at its two Indian plants of Paonta Sahib and Dewas and agreed to a $500 million settlement.
“Daiichi Sankyo believes certain former shareholders of Ranbaxy concealed and misrepresented critical information concerning the US Department of Justice and Food and Drug Administration (FDA) investigations,” Daiichi said in a statement.
FDA warning to Ranbaxy.
Mr. Malvinder Mohan Singh
CEO & Managing Director
Ranbaxy Laboratories Limited
Plot 90; Sector 32
Gurgaon – 122001 (Haryana)
Dear Mr. Singh:
The Center for Drug Evaluation and Research has determined that Ranbaxy Laboratories
Limited (Ranbaxy) submitted untrue statements of material fact in abbreviated and new
drug applications filed with the Agency. These findings concern the submission of
information, such as from stability test results in support of pending and approved drug
applications, from the Ranbaxy Laboratories Limited site located at Paonta Sahib,
Sirmour District, Himachal Pradesh, India, (herein referred to as the “Paonta Sahib site”).
The following are examples of the observations that support our conclusion that Ranbaxy
submitted untrue statements of material fact in drug applications filed with the Agency:
1. Ranbaxy submitted stability information in numerous approved and pending
applications that contain untrue statements of material fact, because Ranbaxy failed to
include critical information about the storage and testing of the product. During a
February 2006 inspection of the Paonta Sahib manufacturing facility, FDA found
that hundreds of stability samples, many of which were being used for room
temperature or accelerated stability studies, were being stored in refrigerators at
approximately between the time they were removed from their stability
chamber and the time they were tested. Among other things, FDA investigators
found that the sample logbooks did not identify the samples that were being held in
the refrigerators, their storage duration in the refrigerators, and the justification for
this storage. FDA issued a June 15, 2006 warning letter to Ranbaxy based on its
findings during this inspection, including the circumstances of these refrigerated
2. Ranbaxy submitted an August 26, 2006 warning letter response that included
corrections to the stability data previously submitted to the agency in several
abbreviated new drug applications (ANDAs). The corrected stability test reports for
Fluconazole Tablets, Ciprofloxacin Tablets, and show instances
where stability test dates that previously had been submitted to the applications were
false. In some cases stability testing was conducted several months later than the
dates reported in the applications. Additionally, the firm reported stability test results
for a given batch as occurring at the required accelerated or long term (e.g., 3, 6, 9, 12
(b) (4) (b) (4)month ) time intervals, but actually conducted all of these tests on the same day, or
within a period of days.”
For Fluconazole Tablets and Ciprofloxacin Tablets, we found that even after Ranbaxy
submitted its August 2006 warning letter response with the corrected stability test
dates, the firm continued to submit the false stability test dates in annual report
submissions to the respective applications.
These submissions of false information about
the stability testing of the products were
material to FDA’s review of the applications.