Croatian Regulator Cites Dhanuka Laboratories for 32 Violations

Indian API maker Dhanuka Laboratories could lose its EU GMP certificate after an inspection turned up 32 violations.

Croatia’s Agency for Medicinal Products and Medical Devices inspected the company’s facility in Gurgaon and spotted one critical violation and seven major ones, prompting its recommendation. The critical issue cited in last week’s noncompliance report concerned the company’s “weak” quality assurance system.

Foremost among the major findings was a potential mix-up of EU-certified batches of the antibiotic Cefixime with unapproved batches.