Sterile Drug Products
Manufacturing

We provide products that meet our clients' needs
through our proven technical expertise and
comprehensive sterility assurance system.

Service Overview

We provide contract manufacturing of Sterile Drug Products under a comprehensive sterility assurance system.
In manufacturing, we use MES (Manufacturing Execution System) to manage the weighing and charging processes, which helps to prevent cross-contamination.
We are proud of our decades-long commitment to solve social issues, driven by our mission to provide a steady supply of essential medicines. We are constantly pursuing a higher level of quality assurance, not just meeting the minimum requirements of regulatory inspections.

Characteristics

We offer comprehensive sterility assurance and
provide solutions tailored to our customers' needs.

Appropriate aseptic environment: The sterile manufacturing area is designed to minimize the risk of contamination during the manufacturing process and provides an appropriate aseptic environment.
Manufacturing in compliance with cGMP: With deep expertise in raw material quality assurance and a thorough understanding of aseptic techniques, our specialized staff performs production in compliance with cGMP.
Thorough implementation of the monitoring improvement cycle: To further enhance our sterility assurance, we regularly monitor the sterile environment and
periodically evaluate the operation status of the production lines to ensure continuous improvements.
Experience in building single-use production lines: With our deep understanding of customers' needs, we have experience in building customized single-use aseptic production lines to ensure the supply of products with guaranteed sterility.

CDMO Available Manufacturing and Development Support

We offer a range of dosage form contract manufacturing

We can handle filling of vials, syringes, and powders formulations

Vial filling
（Lyophilized products）

Filling line (1) : 100 vials/ min,
freeze dryer (1)
Packaging line (1) : 250 vials/min
Inspection line (1)

Syringe filling

Glass syringe filling line (1) ：
80 syringes/min
Plastic syringe filling line (1) ：
120 syringes/min
Packaging line (1) : 140 syringes/min

Powder formulation

Mixer (1)
Filling line (1) : 70 vials/min (Isolator)
Packaging line (2)

Annual Manufacturing Capacity-Formulation

Development Support

Comprehensive technical consulting services

To optimize the stability of injectable drugs, the freeze-drying cycle time is a top priority on those development. To explore high-quality injectable drug manufacturing, we have a technical development area on-site where we support everything from initial condition studies and prototype manufacturing to clinical trial drug production. To ensure a reliable simulation of commercial production, we have a non-GMP pilot-scale manufacturing facility in this area. This setup allows us to seamlessly progress from initial formulation studies to full-scale prototype manufacturing.
We also offer flexible support for product-specific filter validation and process simulation.