United States Food and Drug Administration (USFDA) has issued a warning letter for Jubilant Life Sciences’ (JLL) material wholly owned subsidiary -- Jubilant Pharma’s (JPL) Roorkee facility. The USFDA may withhold approval of any new applications or supplements till the company addresses all issues raised by the agency.
Earlier, USFDA had conducted inspection at one of manufacturing facility at Roorkee, India of solid dosage formulations during August 2018 and the subsequent intimation from the agency of classifying the facility as ‘Official Action Indicated’ (OAI) in December 2018.
Jubilant Life Sciences is an integrated global pharmaceutical and life sciences company engaged in Pharmaceuticals, Life Science Ingredients and Drug Discovery Solutions.
