Key Development

US Food and Drug Administration (USFDA) has granted approval for commercial batch manufacturing of the first product on Line 3 of Jubilant HollisterStier LLC's contract manufacturing facility located in Spokane, U.S.A.

Facility Details

The approved line is described as a new "Isolator based fill and finish line" specifically designed for sterile injectables manufacturing.

Corporate Structure

Jubilant HollisterStier LLC is identified as a subsidiary of Jubilant Pharma Holding Inc., which is itself a subsidiary of Jubilant Pharma Limited, Singapore. Jubilant Pharma Limited, Singapore is a wholly owned subsidiary of Jubilant Pharmova Limited.

Approval Timing

The approval was received on August 21, 2026, at 12:46 PM Pacific Standard Time (PST), which corresponds to August 22, 2026, at 01:16 AM Indian Standard Time (IST).

Business Description - Jubilant HollisterStier LLC

Jubilant HollisterStier is characterized as a leading integrated contract manufacturer of:

  • Sterile injectables (both liquid and lyophilization)
  • Ophthalmics (Ointment, liquid and creams)

The company operates facilities in North America and provides specialized manufacturing services for pharmaceutical and biopharmaceutical industries, offering full range of support from process qualifications through commercial release.

Business Description - Jubilant Pharma Limited

Jubilant Pharma Limited (JPL), incorporated in Singapore, is described as an integrated global pharmaceutical company engaged in:

  • Manufacturing and supply of Radiopharmaceuticals with network of 45 radio-pharmacies in the US
  • Allergy Immunotherapy
  • Contract Manufacturing of Sterile Injectables and Non-sterile products
  • Solid Dosage Formulations through multiple manufacturing facilities

The company serves regulated markets including USA, Europe and other geographies, employing approximately 3,200 multicultural people across the globe and serving customers in over 75 countries.

Business Description - Jubilant Pharmova Limited

Jubilant Pharmova Limited is presented as an integrated global pharmaceutical company with businesses in:

1. Radiopharma (with 45 radiopharmacies in USA)

2. Allergy Immunotherapy (manufacturing allergic extracts and venom products for USA, Canada, Europe, Australia)

3. Contract Development and Manufacturing of sterile injectables (facilities in Spokane, USA and Montreal, Canada)

4. Contract Research Development and Manufacturing (three research centers in India and France, US FDA approved API facility in Nanjangud, Karnataka)

5. Generics (Solid Dosage Formulations for regulated markets)

6. Proprietary Novel Drugs (developing therapies in oncology and auto-immune disorders)

The company employs approximately 5,500 multicultural people globally and positions itself as a 'Partner of Choice' for leading pharmaceutical companies.

Disclaimer

Includes standard forward-looking statements disclaimer noting that statements about future status, events, or circumstances are subject to numerous risks and uncertainties and may not be predictive of future results.