Ranbaxy Says F.D.A. Lists Possible Violations at Punjab Drug Plant


MUMBAI — Ranbaxy Laboratories, India’s largest drug maker, said Monday that the United States Food and Drug Administration had raised concerns about possible violations in manufacturing practices at a plant in the northern state of Punjab.

Ranbaxy said in a statement to the Bombay Stock Exchange that after a recent F.D.A. inspection of the generic drug maker’s facility in Toansa, Punjab, the regulator had given Ranbaxy a form that lists possible violations of the Food, Drug and Cosmetic Act of the United States.

Ranbaxy said it was assessing the document and would work to resolve the regulator’s concerns as soon as possible.

Shares of Ranbaxy fell as much as 9.2 percent on Monday after the announcement, and finished the day down 5.4 percent.

Four months earlier, the F.D.A. announced a ban on any imports made by Ranbaxy’s factory in Mohali, Punjab, causing the drug maker’s stock to fall 30 percent.

Pharmaceutical analysts said that after such a warning, the F.D.A. typically allows the company a period of time to fix the problems identified. If the regulator is not satisfied with the remedial steps, it might issue a warning letter, which precludes new product approvals for the facility until the concerns are addressed but allows the facility to continue to supply products that are already approved.

If the problems are severe, the F.D.A. could issue an import alert, which prohibits a company from shipping products from a particular facility to the United States….

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