Jubilant Pharmova's US CMO facility gets 'Voluntary Action Indicated' classification

Pharma firm Jubilant Pharmova Ltd said on Friday (September 11) that the US Food and Drug Administration (US FDA) has classified its contract manufacturing organisation (CMO) facility in Spokane, Washington, as “Voluntary Action Indicated” (VAI).

The classification follows the US FDA's review of the Establishment Inspection Report (EIR) for an inspection conducted at Jubilant HollisterStier LLC's facility from June 8 to June 17, 2026.

Jubilant HollisterStier LLC is a subsidiary of Jubilant Pharma Holding Inc., which in turn is a subsidiary of Jubilant Pharma Ltd, Singapore. Jubilant Pharma Ltd, Singapore, is a wholly owned subsidiary of Jubilant Pharmova.

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What is an Establishment Inspection Report (EIR)

Based on the inspection and the response given by the company to the US FDA, the FDA will release an Establishment Inspection Report (EIR) within 30 days of the inspection.

The EIR reflects the FDA’s official determination of a factory’s GMP compliance. FDA and the Inspection Classification Database classify the inspection by each project area with one of three classifications.

What is Voluntary Action Indicated (VAI)

Given when violations are found, but the problems do not justify further regulatory action. Improving GMP compliance is voluntary in this case. The facility can continue selling approved drugs and will also receive approvals of new filings.

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Jubilant Pharmova arm gets tentative USFDA approval for Pantoprazole Oral Suspension

Last month, Jubilant Pharmova said it had received approval from the US Food and Drug Administration (USFDA) for commercial batch manufacturing of the first product on Line 3, a new isolator-based fill-and-finish line at its contract manufacturing facility in Spokane, Washington, in the US.

The facility is operated by Jubilant HollisterStier LLC (JHS), a subsidiary of Jubilant Pharma Holding Inc., which in turn is a subsidiary of Jubilant Pharma Limited, Singapore, a wholly owned subsidiary of Jubilant Pharmova. The newly approved Line 3 is an isolator-based fill-and-finish line at JHS's contract manufacturing facility in Spokane.

Jubilant HollisterStier is an integrated contract manufacturer of sterile injectables, including liquid and lyophilised products, as well as ophthalmic products such as ointments, liquids and creams.

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Shares of Jubilant Pharmova Ltd ended at ₹1,025.65, down by ₹0.050, or 0.0049%, on the BSE.