The US regulator banned the drug and active pharmaceutical ingredient (API) firm this week, issuing it a 66-40 import alert. A 66-40 alert is issued when a firm is “not operating in conformity with current good manufacturing practices (GMP's).”
The Nawabpet plant – also called Unit I - is about 40km outside Hyderabad. It produces a range of drug ingredients, including anti-histamines, muscle relaxants and treatments for cardiac disorders.
The news comes less than a year after Fleming paid outstanding registration fees that had earned the facility a US Food and Drug Administration (FDA) in 2014.