FDA-banned Caraco may shift meds to India
What to do when the FDA has cracked down on your U.S. drug production? Perhaps move manufacturing to India. That's what Caraco Pharmaceuticals is considering as it works to resolve the agency's concerns about a U.S. plant, according to the Economic Times. "We may... transfer certain manufactured products to an alternate manufacturing site that could allow the company to gain revenue from those products in less than six months," CEO Jitendra Doshi told the newspaper.
If Caraco does move some drug production to the subcontinent, it could capitalize on its ownership by India's Sun Pharmaceutical Industries. Caraco would dispatch those drugs to an Indian plant operated by its parent company. "The decision to shift manufacturing from Caraco to Sun would be taken on a product-by-product basis," Doshi says. The company may also elect to use Sun to sell some of its marketed products made by third-party manufacturers.
Caraco has been hobbled ever since June, when the FDA ordered U.S. marshals to seize products made in Caraco's Michigan facilities. The agency alleged that Caraco had violated good manufacturing practices, and has since entered into a consent decree requiring the company to correct its manufacturing problems before resuming production there. Even if Caraco decides to have Sun make some of its products, it will still work to bring the Michigan plants back up to speed, Doshi said.
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