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    Croatian Regulator Cites Indian Manufacturer for QA, GMP Violations

    The Agency for Medicinal Products and Medical Devices of Croatia (HALMED) on Monday issued a statement of non-compliance to Indian active pharmaceutical ingredient (API) manufacturer Dhanuka Laboratories Ltd. The notice was issued following an inspection of Dhanuka's Gurgaon, India facility conducted on 19 February 2016, during which inspectors discovered 32 good manufacturing practice (GMP) violations, including one critical violation involving Dhanuka's "weak" quality ...