According to reports from CNBC TV18, Jubilant Pharmova announced 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. As per CNBC TV18, this upgradation from Official Action Indicated (OAI) to VAI is indicative of the cGMP status at the facility since receiving the warning letter in 2013, with the Spokane site's latest EIR indicating successful conclusion of inspections in April 2014 and December 2014.
As reported by CNBC TV18, 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. The facility operates as an integrated contract manufacturer of sterile injectables, including liquid and lyophilised products, as well as ophthalmic products such as ointments, liquids and creams. According to the latest reports, Jubilant Pharmova is a leading player in the US radiopharmaceutical market, supported by a broad product portfolio, in-house API manufacturing, strong supply chain capabilities, and an onshore manufacturing presence in Montreal. The company is engaged in six businesses including Radiopharma, Allergy Immunotherapy, Contract Development and Manufacturing of sterile injectables, Contract Research Development and Manufacturing, Generics and Proprietary Novel Drugs businesses.
According to CNBC TV18, 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, with the FDA and Inspection Classification Database classifying inspections by each project area with one of three classifications. A VAI classification means violations were found but the problems do not justify further regulatory action, with improving GMP compliance being voluntary in this case. As per the latest reports, this upgradation from OAI to VAI indicates the facility's successful transition to cGMP compliance status.
As reported by CNBC TV18, last month, Jubilant Pharmova 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. The facility can continue selling approved drugs and will also receive approvals of new filings despite the VAI classification. According to the latest reports, during the year 2022, the company announced another expansion at the Spokane facility to increase the injectable filling production capacity by 100% from current levels at a cost of US$ 192 million. The facility has also made significant progress with the I131-MIBG program for high-risk neuroblastoma, completing dosing of required patients in the OPTIMUM Phase II clinical trial in April 2024.
According to CNBC TV18, shares of Jubilant Pharmova Ltd ended at ₹1,025.65, down by ₹0.050, or 0.0049%, on the BSE following the announcement. The modest decline reflects investor reaction to the regulatory classification, though the facility's continued ability to manufacture and sell approved products may provide some market reassurance. As of September 11, 2026, the stock is trading at ₹1,025.3 with a market cap of ₹16,351.30 crore. The stock has achieved a return of -9.99% over the past year but showed a positive return of 6.53% in the last month alone.
