Jubilant Pharmova Gets USFDA Nod for New Spokane Fill-Finish Line

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Image Courtesy: Jubilant Pharmova

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 contract manufacturing facility in Spokane, Washington, USA. The new line is operated by Jubilant HollisterStier LLC (JHS), a subsidiary of Jubilant Pharma Holding Inc, which is part of Jubilant Pharma Limited, Singapore. Jubilant Pharma Limited is a wholly owned subsidiary of Jubilant Pharmova Limited.

The approval marks an important milestone in the expansion of Jubilant HollisterStier’s sterile manufacturing capabilities in the United States. The company provides contract manufacturing services to pharmaceutical and biopharmaceutical companies, with expertise in sterile injectables and ophthalmic products.

Jubilant HollisterStier’s Spokane facility supports the manufacturing of sterile injectable products in both liquid and lyophilized formats. Its ophthalmic capabilities include liquids, ointments and creams. The company provides integrated services covering process qualification through commercial manufacturing and product release.

The approval of Line 3 is expected to strengthen the facility’s ability to support customers requiring sterile fill-and-finish manufacturing in regulated markets. The isolator-based technology provides a controlled environment for sterile manufacturing and supports the production requirements of pharmaceutical and biotechnology companies.

The development further strengthens Jubilant Pharmova’s contract manufacturing business and its presence in the global pharmaceutical supply chain. The company continues to expand its capabilities across radiopharmaceuticals, allergy immunotherapy, sterile injectables, contract research and development, generics and proprietary novel drugs.

Jubilant Pharma Limited operates an integrated pharmaceutical business with activities spanning radiopharmaceuticals, allergy immunotherapy, contract manufacturing of sterile and non-sterile products and solid dosage formulations. Its radiopharma business operates a network of 45 radio-pharmacies across the United States and serves customers in multiple markets.

Jubilant HollisterStier has manufacturing operations in North America and provides specialised services to pharmaceutical and biopharmaceutical companies. Its Spokane facility forms a key part of the company’s sterile contract manufacturing network, while another facility in Montreal, Canada, also supports its contract development and manufacturing operations.

Jubilant Pharmova’s contract research and development business operates through three research centres, including two in India and one in France. Its portfolio also includes an USFDA-approved active pharmaceutical ingredient manufacturing facility in Nanjangud, Karnataka.

The company’s generics business develops, manufactures and distributes solid dosage formulations for regulated markets, including the United States and Europe. Its proprietary novel drugs business is focused on developing therapies in areas such as oncology and autoimmune disorders.

With around 5,500 employees globally, Jubilant Pharmova serves pharmaceutical customers across international markets. The USFDA approval for Line 3 adds to its manufacturing capabilities and strengthens its position as a contract manufacturing partner for sterile pharmaceutical products.