+1 201-898-0502
info@sterelynx.com
4002 Southwest Fwy, Houston, Texas 77027, USA
ABOUT US
Sterelynx
about us
Advanced Sterile Packaging Excellence Worldwide
Sterelynx . 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 Sterelynx?
Faster Clinical and Commercial Scale-Up
Lower Operational Risk
Reduced Capital Expenditure On Washing/Sterilization Lines
Strong Fit For Emerging Biotech and CDMO Workflows
Customized RTU Configurations
Dedicated After-Sales Technical Support
Flexible Supply and Delivery Models
Reliable Long-Term Partnership
