Last Updated on October 2, 2024 by The Health Master
Noida: Jubilant Pharmova Limited has recently announced that the United States Food and Drug Administration (USFDA) has issued Form 483 with eight observations pursuant to the completion of the inspection at the company’s API manufacturing facility in Nanjangud, India.
The inspection was concluded on December 13, 2022.
“The company will submit an action plan on the observations and will engage with the USFDA for the next steps,” the company stated in a BSE filing.
Jubilant Pharmova Limited (formerly Jubilant Life Sciences Limited) is a company engaged in specialty pharmaceuticals, contract research, development, and manufacturing (CRDMO), generics, and proprietary novel drug businesses.
Specialty pharmaceuticals, CDMOs, and generics businesses through Jubilant Pharma Limited Singapore (JPL) are engaged in the 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 generic and branded formulations through five manufacturing facilities that cater to all the regulated markets, including the USA, Europe, and other geographies.
Jubilant Pharmova Limited is also involved in the manufacturing of active pharmaceutical ingredients (API) from its USFDA-approved facility in Nanjangud, India.
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