Jubilant Pharmova Gets USFDA Nod for Commercial Batch Manufacturing at New Spokane Fill-Finish Line
Noida: Jubilant Pharmova Limited has announced that the US Food and Drug Administration (USFDA) has approved commercial batch manufacturing of the first product on the new isolator-based fill-and-finish Line 3 at its subsidiary Jubilant HollisterStier LLC's (JHS) contract manufacturing facility in Spokane, Washington, USA.
The approval allows JHS to commence commercial batch manufacturing of the first product on the newly established line at the Spokane facility.
Jubilant HollisterStier LLC is a subsidiary of Jubilant Pharma Holding Inc., which is a subsidiary of Jubilant Pharma Limited, Singapore, a wholly owned subsidiary of Jubilant Pharmova Limited.
Jubilant HollisterStier is an integrated contract manufacturer of sterile injectables, including liquid and lyophilized formulations, as well as ophthalmic products such as liquids, ointments and creams.
The company provides specialized manufacturing services to the pharmaceutical and biopharmaceutical industries from its facilities in North America. Its services cover the manufacturing lifecycle, including process qualification through commercial product release.
The Spokane facility is one of Jubilant HollisterStier's key contract manufacturing sites for sterile injectable products.
Jubilant Pharma Limited, a Singapore-incorporated company and wholly owned subsidiary of Jubilant Pharmova Limited, is an integrated global pharmaceutical company engaged in the manufacture and supply of radiopharmaceuticals, allergy immunotherapy products, contract manufacturing of sterile injectables and non-sterile products, and solid dosage formulations.
The company operates a network of 45 radiopharmacies in the US and has multiple manufacturing facilities serving regulated markets, including the US and Europe, as well as other geographies.
Jubilant Pharma has around 3,200 employees globally and supplies products and services to customers across more than 75 countries.
Jubilant Pharmova is an integrated global pharmaceutical company with businesses spanning radiopharma, allergy immunotherapy, contract development and manufacturing of sterile injectables, contract research, development and manufacturing, generics and proprietary novel drugs.
Its radiopharma business operates a network of 45 radiopharmacies in the US and is engaged in the manufacture and supply of radiopharmaceutical products and services.
The company's allergy immunotherapy business manufactures and supplies allergen extracts and venom products in the US, Canada, Europe and Australia.
Its sterile injectable contract development and manufacturing business has facilities in Spokane, US, and Montreal, Canada, and provides end-to-end manufacturing solutions covering sterile fill-and-finish injectables, including liquid and lyophilized products, as well as ophthalmic products and ampoules.
Jubilant Pharmova's contract research, development and manufacturing business provides drug discovery and development services through three research centers, including two in India and one in France, along with a USFDA-approved active pharmaceutical ingredient manufacturing facility in Nanjangud, Karnataka.
The company's generics business focuses on the development, manufacturing and distribution of solid dosage formulations through multiple manufacturing facilities serving regulated markets, including the US and Europe.
Its proprietary novel drugs business is focused on developing therapies in oncology and autoimmune disorders.
Jubilant Pharmova has a global workforce of around 5,500 employees and is recognized as a partner to pharmaceutical companies worldwide.
