Recognition Built on 30 Years of Innovation

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Recognition Built on 30 Years of Innovation

LINUO holds more than 130+ patents. 20+ standards contributed. China's only Pharmaceutical Glass Training Base.

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130+ Patents - Innovation at the Core

LINUO holds more than 130 registered patents covering the full spectrum of pharmaceutical glass packaging technology. Our intellectual property portfolio reflects three decades of continuous investment in materials science, manufacturing process engineering, and quality assurance systems.

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Dedicated R&D Engineers

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Total Registered Patents

Certifications and Institutional Recognition

LINUO's quality management systems and products are independently verified by leading national and international certification bodies. These certifications are not merely compliance checkboxes — they represent the operational standards our teams uphold every day.

RoHS Verification of Conformity

RoHS Verification of Conformity

FDA Type III DMF Acknowledgement – DMF No. 038426

FDA Type III DMF Acknowledgement – DMF No. 038426

MDR Verification of Conformity – Prefilled Syringe

MDR Verification of Conformity – Prefilled Syringe

ISO 9001 Certified Quality Management System

ISO 9001 Certified Quality Management System

ISO 14001 Certified Environmental Management System

ISO 14001 Certified Environmental Management System

ISO 50001 2018 Energy Management System Certificate

ISO 50001:2018 Energy Management System Certificate

ISO 13485 2016 Medical Devices Quality Management System Certificate

ISO 13485:2016 Medical Devices Quality Management System Certificate

ISO 9001 2005

ISO 9001 2005

Russian certification

Russian certification

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Environmental Management System Certificate

Regulatory Compliance

LINUO's compliance program covers all major international pharmaceutical markets.

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    Standards

    Pharmacopoeia Standards

    All LINUO pharmaceutical primary packaging is manufactured from Type I borosilicate glass and tested to USP <660>, EP 3.2.1, ChP 0672, and JP General Tests — the highest classification for chemical resistance and hydrolytic stability, suitable for biologics, vaccines, and sensitive parenteral drugs.

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    Standards

    FDA DMF Status

    LINUO holds 5 active FDA Drug Master File (DMF) registrations — one for each major product category. Pharmaceutical manufacturers can reference LINUO's DMF in their own FDA submissions without disclosing confidential manufacturing information.

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    Standards

    Certifications

    LINUO holds a comprehensive portfolio of quality, regulatory, and environmental certifications — covering pharmaceutical manufacturing, medical device production, laboratory accreditation, and environmental management. View the full certificate gallery on our About Us — Honors page.

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Setting the Standards for an Industry

LINUO is not simply a participant in China's pharmaceutical glass industry — we help define it. Our technical leadership is recognized at the national level through institutional designations, standards participation, and academic partnerships that no other manufacturer in our sector can match.

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China's Only Pharmaceutical Glass Training Base

LINUO is the sole designated host of China's national Pharmaceutical Glass Training Base — the only facility of its kind in the country. This designation reflects our role as the technical benchmark for the entire pharmaceutical glass packaging industry in China, and underscores our commitment to advancing workforce capability and knowledge transfer across the sector.

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20+ National & Industry Standards Contributed

Our R&D team has actively participated in drafting and revising more than 20 national and industry standards for pharmaceutical glass packaging. These include standards governing:

  • Borosilicate glass composition and classification

  • Dimensional tolerances for injection vials, ampoules, and cartridges

  • Hydrolytic resistance testing methods

  • RTU and sterile packaging system requirements

  • Extractables and leachables testing protocols

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Listed Company & Institutional Transparency

As a publicly listed company on the Shenzhen Stock Exchange (301188.SZ), LINUO is subject to the highest levels of financial disclosure, corporate governance, and regulatory oversight. Our buyers benefit from the transparency and accountability that comes with working with a publicly accountable manufacturer.

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University & Research Partnerships

Our R&D network extends beyond our own facilities through formal partnerships with leading Chinese universities and international research institutions:

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