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US FDA bans APIs made by Fleming Labs
Fleming Laboratories has been banned from shipping APIs to the US by the FDA which says its manufacturing plant in Nawabpet, Telangana in India is not up to code.
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.
