Jubilant Lifesciences announced that in Jubilant Pharma, its material wholly owned subsidiary, with reference to the USFDA inspection conducted 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, the agency has further issued a Warning letter for the Roorkee facility. The USFDA may withhold approval of any new applications or supplements till the company addresses all issues raised by the agency.
However, the company believes that the existing manufacturing and sale of products from this facility will not be impacted. US revenues from the facility is about 4% of the total revenues of the company.
The company is committed to implementing the necessary corrective actions required to address USFDA concerns and is in the process of providing a thorough and comprehensive response to the USFDA within 15 working days.
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