Sterile injectable facility

A dedicated facility for sterile injectable manufacturing

OneSource’s sterile injectables facility in Bengaluru is purpose-built to support the development and manufacturing of sterile injectable products, with a focus on technically demanding formulations and delivery systems.

Spanning approximately 70,000 square feet and supported by over 300 specialists, the facility is designed to deliver consistent, high-quality production for global markets. Its infrastructure, processes, and expertise are aligned to handle the unique challenges associated with sterile injectables, from formulation sensitivity to device integration.

Manufacturing designed for complexity and scale

The facility operates multiple high-capacity production lines supporting both aseptic and terminally sterilized injectable products. These systems are designed to maintain tight control over critical parameters such as sterility, fill accuracy, and product stability.

  • Aseptic liquid filling for vials and prefilled systems
  • Terminal sterilization for suitable formulations
  • Lyophilized product manufacturing with optimized cycle development
  • Integrated support for device-ready formats

A key strength of the facility is its ability to support both traditional injectable formats and more complex delivery systems within the same operational framework.

Injectable manufacturing capacity and formats

Dosage Format Manufacturing Type Annual Capacity
Liquid Vials (Aseptic) Sterile Fill-Finish ~28 Million Units
Liquid Vials (Terminally Sterilized) Terminal Sterilization ~40 Million Units
Dry Powder Vials Sterile Powder Filling ~18 Million Units
Lyophilized Vials Freeze-Dried Injectables ~4 Million Units
Prefilled Syringes Device-Integrated ~10 Million Units*
Device-Integrated Systems Autoinjectors / Pen Systems

*Capacity based on current device-line throughput.

Advanced lyophilization and process optimization

Lyophilization is a critical capability for many sterile injectable products, particularly for peptides, biologics, and temperature-sensitive formulations.

This expertise enables more efficient manufacturing while maintaining product stability and quality.

At OneSource, lyophilization processes are supported by:

  • Cycle development and optimization aligned with product characteristics
  • Scale-up strategies to maintain consistency across batch sizes
  • Process modeling to reduce cycle times and improve efficiency

Integrated device assembly for patient-centric delivery

Beyond sterile manufacturing, the facility supports integration with delivery devices, enabling the production of patient-ready injectable systems.

Capabilities include:

  • Prefilled syringe assembly
  • Autoinjector integration
  • Support for pen-based delivery systems

These capabilities allow injectable products to be developed and manufactured with final delivery in mind, supporting self-administration and improved patient adherence.

Infrastructure supporting flexible execution

The facility is supported by infrastructure designed to ensure consistent performance and control across all manufacturing activities.

Key features include:

Controlled cleanroom environments for sterile manufacturing

Dedicated areas for aseptic and terminal sterilization processes

Integrated packaging and inspection systems

Warehousing and cold storage capabilities for temperature-sensitive products

Together, these systems support reliable production and consistent product quality.

Quality and compliance at global standards

The sterile injectables facility operates under stringent cGMP conditions and is approved by multiple global regulatory authorities.

Regulatory approvals include:

  • US FDA
  • TGA
  • Health Canada
  • ANVISA
  • EMA

These approvals enable supply into highly regulated markets and reflect a strong track record of compliance and inspection readiness.

Enabling global supply of sterile injectable therapies

The facility is designed not only for manufacturing, but for reliable global supply.
With integrated capabilities spanning formulation support, sterile manufacturing, device assembly, and packaging, OneSource enables partners to bring sterile injectable products to market efficiently and at scale.
This includes support for emerging therapies such as peptide-based injectables and drug-device-combination products, where precision, consistency, and integration are critical to success.

Sterile manufacturing and device integration for advanced injectable products

Sy No. 154/11, Bilekahalli,
Bannerghatta Road,
Bengaluru – 560076, India

Develop sterile injectables with confidence

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