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The US Food & Drug Administration (USFDA) has issued a warning letter to Mylan Laboratories for violation of current good manufacturing practice (CGMP) norms at its three plants in Karnataka.
The US regulator said its inspectors found “significant violations” in the three manufacturing facilities in Bengaluru of the company, which is an arm of US-based Mylan Inc.
Of the three units, two plants belonged to Agila Specialties, which Mylan had acquired from Strides Arcolab in 2013. The other unit is owned by Mylan Laboratories.
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