Jubilant Pharmova Receives 8 USFDA Observations for Spokane Facility
New Delhi: Jubilant Pharmova Limited has announced the successful completion of a United States Food and Drug Administration (USFDA) inspection at the Spokane, Washington manufacturing facility of its subsidiary, Jubilant HollisterStier LLC (JHS), with the regulator issuing eight observations at the conclusion of the inspection.
According to a disclosure submitted by the company to the stock exchanges, the USFDA completed the inspection of JHS' contract manufacturing organization (CMO) facility in Spokane on June 17, 2026. The company stated that none of the eight observations issued by the regulator were related to sterility assurance concerns.
"The USFDA had issued eight (8) observations, none of which are related to sterility assurance concerns," the company said in its filing.
Jubilant Pharmova further informed investors that Jubilant HollisterStier will respond to the observations within the stipulated timeline of 15 business days and remains committed to addressing the issues comprehensively.
Jubilant HollisterStier LLC is 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 Limited.
Jubilant HollisterStier is an integrated contract manufacturer specializing in sterile injectables, including liquid and lyophilized products, as well as ophthalmic formulations such as ointments, liquids and creams. The company operates manufacturing facilities in North America and provides contract manufacturing services to pharmaceutical and biopharmaceutical companies.
Jubilant Pharma Limited's business portfolio includes radiopharmaceuticals, allergy immunotherapy products, sterile injectable and non-sterile contract manufacturing services, as well as solid dosage formulations supplied to regulated markets including the United States and Europe. The company operates a network of 45 radiopharmacies across the United States and serves customers in more than 75 countries.
Jubilant Pharmova, the parent company, is engaged in radiopharma, allergy immunotherapy, contract development and manufacturing of sterile injectables, contract research and development services, generics, and proprietary novel drug development. The company employs approximately 5,500 people globally and operates research and manufacturing facilities across India, North America, and Europe.
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