FDA warns India’s Sun Pharma over standards at Halol plant
By Zeba Siddiqui MUMBAI (Reuters) – India's largest drugmaker Sun Pharmaceutical Industries Ltd has been warned by U.S. health regulators for violating manufacturing standards at its Halol plant in India, even as it has been working on fixing issues at the plant for over a year. The U.S. Food and Drug Administration's “warning letter” to Sun Pharma indicates the agency is dissatisfied with the remedial measures the company has implemented since last September, when the FDA first notified the company of its concerns after an inspection.
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FDA warns India’s Sun Pharma over standards at Halol plant