Ranbaxy manufacturing drama continues with FDA action on API plant

FDA actions against Ranbaxy Laboratories have seriously narrowed its options for manufacturing drugs for the U.S. With its three FDA-approved Indian plants banned from shipping to this market, only its Ohm Laboratories plant in New Jersey is currently able to turn out product for a market that accounts for 40% of its revenues. Now there is a possible hurdle for that plant. The FDA has raised questions about manufacturing practices at the active pharmaceutical plant (API) that supplies about 70% of the raw ingredients for U.S. production, Ranbaxy's facility in Toansa.

The latest action has left Ranbaxy watchers shaking their heads and wondering what it will take for the Indian company to get its footing. "If this plant also comes into FDA issues, it means that the company has not spruced up its quality controls even four years after continued FDA supervision," Arvind Bothra, an analyst at investment firm Religare in New Delhi, told The New York Times. "That raises concerns whether overall the company would be able to come out of this FDA scrutiny."

Ranbaxy disclosed in a statement to the Bombay Stock Exchange (BSE) on Monday that the FDA had left a Form 483 with observations following an inspection at its API plant in Toansa. "The company is assessing the observations, and will respond to the U.S. FDA in accordance with the agency's procedure to resolve the concerns at the earliest," it said. No details were provided on how serious the issues were or how many were raised.

With the FDA's import ban in September against Ranbaxy's Mohali plant, all three of its FDA-approved facilities in India have been cut off from the U.S. market, its largest. That leaves only its Ohm Laboratories plant in New Jersey to supply drugs in the U.S. That action came four months after the Indian generic drugmaker pleaded guilty to felony charges and handed over $500 million for having made subpar products for the U.S., then lying about it. That discovery came more than 5 years ago, and the Indian company has been under heavy FDA scrutiny since. In 2012, it signed a 55-page consent decree that lays out specific requirements which it is supposed to live up to. But within months after that document was signed, it had run into problems manufacturing generic Lipitor at the Mohali plant and had to recall 41 lots.

The Indian company insists it is making progress and Monday renewed its pledge to satisfy the FDA: "Ranbaxy continues to improve its systems and processes, and remains fully committed to upholding the highest standards that patients, prescribers, regulators and all other stakeholders expect from the company. Ranbaxy stays firmly committed to its philosophy of Quality and Patients First."

- here's the BSE notice
- read the New York Times story (sub. req.)
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