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warning-letter

India’s Cadila gets FDA warning for violating standards at 2 plants

India’s Cadila Healthcare Ltd said it had received a “warning letter” from the U.S. Food and Drug Administration for violating manufacturing standards at two of its production sites in India, sending its shares down 15 percent on Thursday. The company said its Moraiya and Ahmedabad facilities have been cited in the letter, and it is working on responding to the FDA concerns regarding the sites. None of Cadila’s products being sold in the United States use any raw materials made at the Ahmedabad plant, it added.

India’s Dr Reddy’s gets FDA warning on three drug plants

By Zeba Siddiqui MUMBAI (Reuters) – Dr Reddy’s Laboratories Ltd, India’s second-largest drugmaker by sales, said on Friday it has received a “warning letter” from the U.S. Food and Drug Administration over what the regulator has deemed inadequate quality control procedures at three manufacturing plants in southern India. The warning letter means Dr Reddy’s will not receive FDA approvals to sell drugs manufactured at the plants for now, a blow for business at a company which relies on the United States for a majority of its sales. The plants make a significant contribution to company sales, with one alone accounting for 10-12 percent, Dr Reddy’s said.