FDA sidelines Caraco meds after quality issues

As one Indian pharma continues negotiating for the freedom of its imported meds, U.S. Marshals have seized another India-based drugmaker's stocks made in the U.S. Caraco Pharmaceutical, the U.S. subsidiary of India's Sun Pharmaceutical, saw 33 products made at facilities in Michigan--and the active ingredients held there--commandeered at the FDA's order. The seizure follows a series of recalls that stemmed from manufacturing defects.

The agency said that Caraco has repeatedly failed to meet Good Manufacturing Practice requirements; the seizure is designed to keep its drugs off the market until Caraco complies with those standards. "The FDA is committed to taking enforcement action against firms that do not manufacture drugs in accordance with our good manufacturing practice requirements," said Janet Woodcock, M.D., director of the FDA's Center for Drug Evaluation and Research. "Compliance with these standards prevents harm to the public."

According to India's Economic Times, the 33 seized drugs could affect Caraco's U.S. sales by 6 percent to 7 percent. The company estimated the value of the seized inventory at $15 million to $20 million.

The Caraco news comes at a time when another big Indian pharma company has run afoul of the FDA. Inspection data problems at Ranbaxy Laboratories led to an importation ban that the company is still negotiating with the FDA to lift. And the news comes just as healthcare reform in the U.S., and pricing pressures globally, privilege generic meds. RBC Capital Markets analyst Adam Greene told Dow Jones that quality is becoming more of an issue in the generic-drug marketplace. The Caraco seizure, he said, shines a spotlight on the "long list" of generics that have suffered "significant deviations from current good manufacturing practices over the last 12 months."

- read the FDA release
[1]- see the news [2] from the Times
- get more [3] from Dow Jones

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