Topic: plant inspections

EMA nails Artemis India plant over manufacturing issues

Another Indian API maker is in trouble over manufacturing issues. This time it is an Artemis Biotech plant in Hyderabad and it is the German drug authority that did the legwork, leading to the recommendation that EU countries not accept the company's simvastatin APIs, plus the possibility its plant certification will be yanked.
Pills

EMA bans APIs from two Indian manufacturers

On the recommendation of Italian inspectors, the European Medicines Agency has banned and recommended the recall of APIs manufactured by two Indian manufacturing facilities, a JP Laboratories unit in Maharashtra and a Krebs Biochemicals & Industries plant in Andhra Pradesh.