Jubilant Pharmova said that the United States Food and Drug Administration (USFDA) has concluded audit of the Radiopharmaceutical manufacturing facility at Montreal, Canada.
The said facility is operated by Jubilant Draximage Inc., a subsidiary of Jubilant Pharma (JPL), which is a wholly-owned subsidiary of Jubilant Pharmova. JPL is an ntegrated global pharmaceutical company engaged in manufacturing and supply of Radiopharmaceuticals with a network of 46 radio-pharmacies in the US; allergy immunotherapy, contract manufacturing of sterile injectables and non-sterile products and solid dosage formulations through five manufacturing facilities that cater to all the regulated market including USA, Europe and other geographies.
"The USFDA has issued 5 observations pursuant to the completion of audit. The company will submit an action plan on the observations," Jubilant Pharmova 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.
The pharmaco 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.
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