JUBLPHARMA · price
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Jubilant Pharmova's joint venture, Jubilant HollisterStier General Partnership (JHSGP), has received a USFDA Warning Letter following an inspection review of its Kirkland, Canada facility conducted in October-November 2025. The USFDA completed its review of the Establishment Inspection Report and issued the Warning Letter. JHSGP is actively engaging with the USFDA and has already initiated corrective and preventive actions. The company states that current operations at JHSGP are proceeding under enhanced controls and oversight while remediation efforts are underway. JHSGP is a key contributor to the company's global CDMO capabilities, offering contract manufacturing of sterile products including liquid and lyophilized injectables, ophthalmic solutions, and sterile ointments.
A USFDA Warning Letter for a contract manufacturing facility could raise concerns among clients relying on JHSGP for sterile injectable manufacturing, potentially affecting revenue from that facility until remediation is completed and the warning is lifted.