Jubilant Pharma's ratings unaffected by USFDA warning, Fitch says

Jubilant Pharma’s credit profile remains unaffected by the US Food and Drug Administration's (USFDA) recent regulatory action at its Roorkee facility in India, Fitch Ratings has said. “The plant makes generic solid-dosage products and has limited contribution to JPL's revenue and earnings due to the Singapore-based company's greater focus on specialty-pharmaceutical segments,” the agency said. COIMBATORE: Jubilant Pharma’s credit profile remains unaffected by the US Food and Drug Administration's (USFDA) recent regulatory action at its Roorkee facility in India, Fitch Ratings has said. “The plant makes generic solid-dosage products and has limited contribution to JPL's revenue and earnings due to the Singapore-based company's greater focus on specialty-pharmaceutical segments,” the agency said. The USFDA issued a warning letter for the Roorkee facility on March 6 after having classified it under ‘Official Action Indicated (OAI)’ status in December 2018. The warning letter suggests that the USFDA may withhold approval of any new products until the company addresses compliance-related issues raised by the agency on manufacturing practices.