In a regulatory filing, the company informed that the United States Food and Drug Administration (US FDA) has concluded audit of the solid dosage formulations facility on 2 February 2024 at Roorkee site of Jubilant Generics, a subsidiary of its wholly owned subsidiary Jubilant Pharma.

The USFDA has issued 4 observations pursuant to the completion of audit. The company will submit an action plan on the observations.

"The company currently supplies only one product to US from Roorkee facility, that contributed less than one percent of Jubilant Pharmova’s 9M’FY24 revenues,” Jubilant Pharmova stated.

The company has also announced its earnings for the quarter ended on 31 December 2023. Jubilant Pharmova has reported a net profit of Rs 66 crore in Q3 FY24 as against a net loss of Rs 16 crore in Q3 FY23.

Total income increased by 10% YoY to Rs 1,713 crore during the period under review. This was on account of growth in 'Ruby-Fill’ product sales and new product sales in radiopharmaceuticals, volume growth in radiopharmacies, continued growth momentum in allergy immunotherapy business, growth in CDMO sterile injectables and growth in other income.

EBITDA improved by 63% to Rs 254 crore in Q3 FY24 from Rs 155 crore in Q3 FY23. EBITDA margin in Q3 FY24 was 14.8% as against 9.9% in Q3 FY23.

"In line with the management’s guidance, Radiopharmacy business has pivoted to profitability in FY24. The generics business is also moving towards profitability,” the company said in a statement.

Jubilant Pharmova is engaged in radiopharma, allergy immunotherapy, CDMO of sterile injectable, generics, contract research development and manufacturing (CRDMO) and proprietary novel drugs businesses.