Ranbaxy made “untrue” statement in filings says FDA
The US Food and Drug Administration (FDA) said the falsehoods are connected with various stability data sets submitted as part of applications for various generic drugs manufactured at the plant, including the antibiotics fluconazole and ciprofloxacin and the heart disease drug simvastatin.
One of the recurring allegations made in the latest letter is that tests purporting to cover stability analysis over a nine month period were actually carried out on the “same day or within a few days of each other.”
In September last year, the agency said the Paonta Sahib plant was the subject of an import ban along with two other of Ranbaxy’s Indian facilities in Dewas and Batamandi after inspections uncovered several breaches of US good manufacturing practice (GMP) standards.
Deborah Autor, director of the FDA’s center for drug evaluation and research’s (CDER) office of compliance, said the latest investigations, on which the falsifications allegations are based, had “revealed a pattern of questionable data raising significant questions regarding the reliability of certain applications.”
As a result, the FDA will continue its examination of the plant under its application integrity policy (AIP) and has asked Ranbaxy to resolve all questions of data reliability and integrity and, if necessary, implement a corrective action operating plan (COAP) that may include third-party audits.
While Ranbaxy declined to provide additional comment, a statement issued by the firm stressed that: “The FDA has said it has no evidence the drugs on the market are substandard and also that they comply with specifications upon testing.”
The company added it work with the FDA and that “no effort or action will be spared to timely protect key ANDAs from Paonta Sahib, which include some first to file applications.”
Speaking about the import ban last month, Ranbaxy CEO Malvinder Singh told Reuters that the company may shift production to its US sites in New Jersey until the problems are addressed. The latest FDA move makes such action more likely.
Japanese drugmaker Daiichi Sankyo, which bought Ranbaxy last year, has not commented on the latest revelations.
