USFDA concludes audit at Jubilant Generics Roorkee site
Noida: Jubilant Pharmova Limited announced that the United States Food and Drug Administration (USFDA) has concluded audit of the solid dosage formulations facility on February 2, 2024 at Roorkee site, India of Jubilant Generics Limited (‘Company’), a subsidiary of its wholly owned subsidiary Jubilant Pharma Limited.
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.
Read also: Jubilant Generics Roorkee facility determined as official action indicated
Jubilant Pharma Limited, a Company incorporated under the laws of Singapore and a wholly-owned subsidiary of Jubilant Pharmova Limited, is an integrated 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.
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