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2 min read | Updated on March 13, 2025, 09:32 IST
SUMMARY
Jubilant Pharmova share price: A VAI inspection classification indicates that, although investigators found and documented objectionable conditions during the inspection, the FDA will not take or recommend regulatory or enforcement action because the objectionable conditions do not meet the threshold for action at this time.
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Shares of Jubilant Pharmova have rallied over 60% in the past 12 months. | Image: Shutterstock
On Tuesday, the company, in its filing to stock exchanges, said that the company’s subsidiary Jubilant Cadista Pharmaceuticals Inc., USA, (Jubilant Cadista)’s solid oral formulations facility at Salisbury, Maryland, USA (Facility) has received the Establishment Inspection Report (EIR) with Voluntary Action Indicated (VAI) status from the US Food and Drug Administration (USFDA) for the said Facility with respect to the inspection conducted by the said regulatory agency in January 2025.
A VAI inspection classification indicates that, although investigators found and documented objectionable conditions during the inspection, the FDA will not take or recommend regulatory or enforcement action because the objectionable conditions do not meet the threshold for action at this time.
With the receipt of the EIR from the USFDA, the inspection stands successfully closed, the company added.
Going forward, the said facility is not expected to manufacture any products, as it has closed manufacturing operations, as was informed in the company’s previous disclosure dated April 18, 2024, the filing said further.
Jubilant Cadista has received communication from the USFDA at 09:27 pm (IST) on Tuesday, March 11, 2025.
Jubilant Pharmova (formerly Jubilant Life Sciences Limited) is a global pharmaceutical company with a focus on pharmaceuticals, contract research and development, and proprietary novel drugs, with a presence in Radiopharma, Allergy Immunotherapy, CDMO Sterile Injectables, and Generics.
Shares of Jubilant Pharmova have rallied over 60% in the past 12 months.
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