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news.The US Food and Drug Administration (FDA) has banned Dr Reddy's from selling drugs manufactured at its Mexico chemical facility - Industrias Quimicas Falcon de Mexico - for violating the regulator's manufacturing quality norms.
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Dr Reddy’s‘ Mexican facility manufactures intermediates and active pharmaceutical ingredients (APIs) for use in generic medicines.
The FDA’s decision follows the issuance of warning letter to the company in November 2010 following an inspection.
During the inspection the agency had identified deviations from current good manufacturing practice (cGMP) for the manufacture of APIs.
The US regulator had also asked the Indian firm to take measures to rectify the issues that are raised in the warning letter.