REQUEST A QUOTE
×
“Strategic Process Backed by Proven Science”
Sterelyx RTU






OUR VISION

To be a globally trusted supplier of
Ready-To-Use sterile packaging
and advanced delivery systems for injectable therapies worldwide.

OUR MISSION

  • Deliver US FDA-aligned primary packaging and device solutions.
  • Support pharmaceutical innovation through reliable, future-ready platforms.
  • Build long-term partnerships through quality, transparency, and supply assurance.






about us

Advanced Sterile Packaging Excellence Worldwide

STERELYX Inc. delivers Ready-To-Use (RTU) sterile primary packaging systems and advanced drug delivery platforms for injectables, biologics, vaccines, and specialty pharmaceuticals.

Our operations are supported by highly integrated, globally compliant manufacturing capabilities, ensuring regulatory alignment, consistent quality, and cost efficiency across the supply chain.

Designed to meet the needs of both emerging biotech innovators and established pharmaceutical organizations, our solutions enable accelerated scale-up while minimizing operational complexity and regulatory risk.

PRODUCTION

Certified Manufacturing Excellence

ISO 9001 and ISO 15378 certified facilities operating at GMP standards, ensuring safe, reliable production under strictly controlled temperature and humidity conditions.

1

ISO 15378 Certified

Primary Packaging for Medicinal Products compliant with international regulatory standards.

2

ISO 9001 Quality Management

Robust quality systems ensuring consistency, safety, and operational excellence.

3

GMP Compliant Production

Manufacturing facilities aligned with GMP standards under strictly monitored environmental controls.

4

DMF

Support & Regulatory documentation readiness for US FDA submissions.

Why Choose STERELYX?



Done Icon

Faster Clinical and Commercial Scale-Up

Done Icon

Lower Operational Risk

Done Icon

Reduced Capital Expenditure On Washing/Sterilization Lines

Done Icon

Strong Fit For Emerging Biotech and CDMO Workflows

Done Icon

Customized RTU Configurations

Done Icon

Dedicated After-Sales Technical Support

Done Icon

Flexible Supply and Delivery Models

Done Icon

Reliable Long-Term Partnership

“Experience STERELYX Quality, Sterility & Consistency”
Phone Email