Ranbaxy’s Mohali unit barred from supplying products to US market - The New Indian Express

Ranbaxy’s Mohali unit barred from supplying products to US market

Published: 18th September 2013 08:27 AM

Last Updated: 18th September 2013 08:28 AM

The US Food and Drugs Administration (US FDA) extended the consent decree to Ranbaxy Laboratories Ltd’s Mohali unit, which was slapped with an import alert last week.

The consent decree means that Ranbaxy would be barred from filing new product applications or supplying any products from its Mohali facility to the US until the decree is lifted.

“... the Mohali facility be subject to certain terms of the consent decree of permanent injunction entered against Ranbaxy in January 2012,” the FDA said in a statement issued on September 16.

The decree contains provisions to ensure CGMP (Current Good Manufacturing Practices) compliance at certain Ranbaxy facilities, including in Paonta Sahib and Dewas, India, as well as provisions addressing data integrity issues at those two facilities, US FDA said.

The FDA had conducted inspections at Ranbaxy’s Mohali facility in 2012 and identified significant violations of manufacturing norms, including failure to adequately investigate manufacturing problems and the failure to establish adequate procedures to ensure manufacturing quality.

“Ranbaxy will review the details and will continue to fully cooperate with the US FDA and take all necessary steps to resolve the concerns at the earliest,” the company said.

Ranbaxy is expected to hire a third-party consultant to conduct a thorough inspection of the facility and certify to the regulator that the facilities, methods, processes and controls are adequate to ensure continuous compliance with CGMP norms.

While usually consent decrees are signed between the company and the regulator, in this particular incicent, the FDA has exercised its authority, under a provision in the consent decree, to extend it to Mohali facility, after an inspection determined violations.

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