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FDA warns Dr Reddy's over Mexico plant standards

MUMBAI (Reuters) - The U.S. Food and Drug Administration said it had issued a warning letter to the Mexican facility of Indian drug maker Dr Reddy's Laboratories Ltd for violating manufacturing standards. The FDA said on Tuesday failure to correct these may see the regulator refuse entry into the U.S. of products manufactured at Dr Reddy's Mexican facility, a key export market for the firm. Dr Reddy's, India's second-largest drugmaker by sales, said in a separate statement it would work with the FDA and respond to its observations to resolve the matter. Indian generic drugmakers including rival Ranbaxy are poised to benefit as drugs worth about $100 billion lose patent protection over the next two years. But they face intense competition, rising lawsuits from rival firms and stricter U.S. regulation in their race for the lucrative off-patent market. Many manufacturers have fallen foul of the FDA over standards and processes. In 2009, the FDA accused Ranbaxy of falsifying test results and data in drug applications, and halted reviews of products from the firm's Paonta Sahib plant in northern India. Smaller rival Aurobindo Pharma said in February shipments from a unit in the Indian state of Andhra Pradesh to the U.S. market would be affected after the FDA imposed a ban on imports from the facility. On Tuesday, the FDA said it had identified "significant deviations from current good manufacturing practice (CGMP)," for making active pharmaceutical ingredients (APIs) at Dr Reddy's Mexican facility during an inspection last November. The FDA said it had reviewed Dr Reddy's response to the observations and found it lacked sufficient corrective actions, following which it decided to issue the warning letter. "If you wish to continue to ship APIs to the United States, it is the responsibility of your firm to ensure compliance with all U.S. standards for CGMP and all applicable U.S. laws and regulations," the FDA said in its letter to Dr Reddy's. The U.S. regulator asked the Indian firm to say what steps it had taken to correct the violations and prevent their recurrence, within 15 days of receipt of the letter. "Dr Reddy's takes these matters seriously and will respond to the USFDA within the stipulated timeframe," the Indian drug maker said in a statement, in response to the warning letter issued by the FDA. Shares in Dr Reddy's, which the market values at nearly $6 billion, ended 1.2 percent higher on Tuesday at 1,554.90 rupees in the Mumbai market that rose 0.3 percent. (Reporting by Sumeet Chatterjee; editing by David Hulmes)