Continued manufacturing violations at Ranbaxy Laboratories facilities in India have prompted the U.S. Food and Drug Administration to block import of its products into the United States.
Ranbaxy is one of India’s largest drug manufacturers and a subsidiary of Daiichi Sankyo since 2008. The latest alert is the third the company has received since the FDA cited Ranbaxy for failing to meet its strict guidelines to ensure the quality and safety of drugs, termed current good manufacturing practice, or CGMP.
The problem this time concerns the company’s manufacturing site in Mohali, India, which formerly produced generic Lipitor for export to the United States. Ranbaxy halted production last year after tiny pieces of glass were found in the tablets. In September and December 2012 the FDA reported violations there that included failures to adequately investigate manufacturing problems and to establish adequate procedures that ensure manufacturing quality.
In January 2012, the FDA filed a consent decree against Ranbaxy ordering it to remedy and comply with data integrity issues at sites in both India and the United States before the agency would resume reviewing drug applications from the company.
“Because this company continued to violate current good manufacturing practice regulations and falsify information on drug applications, the FDA took these actions in an effort to protect consumers,” said Dara Corrigan, FDA associate commissioner for regulatory affairs, at the time.
Two of the Indian sites listed in that decree have been on import alert since 2008, and the company’s American site was closed. Now the Mohali facility is also subject to certain terms of that decree and Ranbaxy must hire a third-party expert to inspect and certify the facility, its methods, processes and controls, and data integrity management.
Analysts say Ranbaxy had planned to use the Mohali plant to ramp up the production and exports of new generic drugs, something that investors had hoped would help bolster the Indian company's revenue.
September 17, 2013
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