Ranbaxy hit as third plant comes under FDA import alert

pharmafile | September 17, 2013 | News story | Manufacturing and Production Ranbaxy 

Shares in Ranbaxy have gone on the slide after the FDA issued an import alert on products made at one of its facilities after a failed inspection.

Two of Ranbaxy’s plants are already under FDA import alerts, and the addition of a third unit in Mohali, Punjab province to a January 2012 consent decree with the FDA wiped almost a third off the company’s share price.

Rumours of problems at the Mohali facility surfaced over the summer when local news reports suggested the plant had been issued with a Form 483 notice by the FDA, and the quality deficiencies were holding up approval of the company’s generic version of Novartis’ big-selling antihypertensive Diovan (valsartan) in the US.

The FDA’s action means that imports of drugs made at the Mohali may be intercepted on entry into the US, and the company will be under scrutiny until it brings its operations into compliance with Good Manufacturing Practices (GMP).

The company is also required to hire a third-party expert to conduct a thorough inspection of the plant and certify to the FDA that the “facilities, methods, processes, and controls are adequate to ensure continuous compliance”.

Ranbaxy’s Ponta Sahib and Dewas facilities have been operating under an import alert since 2009, and the transgressions eventually led to a $500 million settlement earlier this year by the US government for selling adulterated medicines.

Howard Sklamberg, director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research (CDER), said the enforcement action was taken “to ensure that drugs made for the US market meet federally mandated quality standards”.

The agency does not anticipate that this action will cause a supply disruption or shortage of drugs in the US.

Towards the end of 2012, Ranbaxy was forced to recall its generic version of the cholesterol drug atorvastatin after tiny glass particles were found in dozens of batches, although it has not emerged whether the material was made at Mohali or the drugmaker’s US subsidiary Ohm Laboratories subsidiary, which makes the ingredient at a facility in New Brunswick.

In a statement issued this morning, Ranbaxy said it 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 added that the FDA last inspected the Mohali facility in 2012, and since then it has made “further improvements” at the plant.

“Ranbaxy is hopeful of an early resolution of these concerns,” said the drugmaker.

Phil Taylor


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