Jubilant Pharmova gets 8 USFDA obervations for Nanjangud facility
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Noida: Jubilant Pharmova Limited has recently announced that the United States Food and Drug Administration (USFDA) has issued eight observations pursuant to the completion of the inspection at the company's API manufacturing facility at Nanjangud, India.
The inspection was concluded on December 13, 2022.
"The company will submit an action plan on the observations and will engage with US FDA for next steps," the company stated in a BSE filing.
Read also: Jubilant Generics Roorkee facility determined as official action indicated
Jubilant Pharmova Limited (formerly Jubilant Life Sciences Limited) is a company engaged in Specialty Pharmaceuticals, Contract Research, Development, and Manufacturing (CRDMO), CDMO, Generics, and Proprietary Novel Drugs businesses. Specialty Pharmaceuticals, CDMO, and Generics businesses through Jubilant Pharma Limited Singapore (JPL) is engaged in manufacturing and supply of Radiopharmaceuticals with a network of radiopharmacies in the US, Allergy Immunotherapy, Contract Manufacturing of Sterile Injectables and Non-sterile products and Generics/branded formulations through five manufacturing facilities that cater to all the regulated markets including USA, Europe and other geographies. Jubilant Pharmova Limited is also involved in manufacturing of Active Pharmaceutical Ingredients (API) from its USFDA-approved facility in Nanjangud, India.
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