FDA, EMA Disagree Over Safety Risks at India Plant
European regulatory authorities have reinstated the GMP certificate at Ranbaxy Laboratories’ API manufacturing site in Toansa, India, but the U.S. FDA is still not satisfied that the plant has complied with safety norms and put adequate corrective measures in place.
Following inspections by the EMA and the FDA last January, both agencies placed restrictions on the Toansa facility after identifying significant manufacturing and quality violations.
The EMA now says its latest assessment shows the deficiencies at the Toansa facility pose no risk to public health.
The Toansa site supplies APIs for four EMA "centrally authorized" drugs – three anti-diabetic drugs (Enyglid, Repaglinide Krka, Repaglinide Teva) and one HIV drug, Nevirapine Teva.
Read the Business Standard press release