inno.N

Company Overview

innovate New & Next,
inno.N is making the leap towards becoming the next global bio health care company.

inno.N's Production Site

With a global Standard IT system and priority placed on the data integrity, inno.N operates a quality management system in accordance with the standards of cGMP/EU GMP.

Enterprise Quality Management System

  • Quality
    Management

    Policies to improve product quality are established and a quality management system is operated.
  • Quality
    Assurance

    The quality of drugs is guaranteed by meeting cGMP standards.
  • Quality
    Improvement

    Through technological support, inno.N aims not only to offer good products, but those that meet some of the most stringent quality standards.
  • Quality
    Audits

    Through continuous quality audits, one of the most thorough quality management systems is maintained and managed.

About the quality system

inno.N operates an Enterprise Quality Management System to ensure the safety of the pharmaceutical products, from their R&D stage to the moment they are administered to patients. Continuous quality management, quality assurance and quality improvement activities are carried out to produce drugs that meet the standards of cGMP for safety, stability and efficacy.
The quality teams on each site of inno.N establish quality policies, conduct quality audits throughout the entire site and offers technical support to maintain and manage the quality management system.

Quality Policy

OUR MISSION

Heal the World for a Better Life

Code of Conduct

  • We always listen to our customers and do our best to respond to their needs, fulfilling our social responsibilities for the patients suffering from disease and their families.
  • We constantly improve with the New Frontier spirit for better quality.
  • We follow principles and standards for quality and act honestly.
  • We strive to have the appropriate members and systems to improve quality.

One of the most cutting-edge production facilities for pharmaceutical products in Korea that meets global standards, the Osong Plant is where high quality oral solid dosage products, Oncology Injectables and IV fluids are manufactured.

  • 01

    Compliance with cGMP/EU GMP

  • 02

    Cutting-edge manufacturing facilities and an IT system for the full production process

  • 03

    Production technologies and hands-on experience from over 30 years in the industry

  • 04

    Compliance with global standards for safety and environment

Address 239, Osong Saengmyeong 2 Ro, Osong-Eup, Heungdeok-Gu, Cheongju-Si, Chungcheongbuk-Do, Korea
Area of the site 146,013 m²
Area of the buildings 58,896 m²
Key facilities 14 buildings specializing each in the manufacturing of oral solid dosage products, Oncology Injectables and IV fluids
Dosage forms of products Oral solid dosage products, Oncology Injectables and IV fluids
Certifications KOSHA-MS, ISO 45001, ISO 14001, KGMP

Oral solid dosage products

Products can be manufactured to various scales using a closed system.

Oncology Injectables

A plant dedicated to the manufacturing of Oncology Injectables with cytotoxicity, it is equipped with a completely closed system to prevent contamination.

One of the largest smart factory in Korea with the latest automated facilities, the Osong IV Plant manufactures some of the highest quality IV products.

  • 01

    One of the largest production capacities in Korea with the latest automated facilities

  • 02

    A smart factory that operates based on Big Data analysis and forecasting

  • 03

    An environment-friendly production facility using renewable energy sources such as solar power

  • 04

    A global quality management system is implemented to ensure the highest quality in products

Address 239, Osong Saengmyeong 2 Ro, Osong-Eup, Heungdeok-Gu, Cheongju-Si, Chungcheongbuk-Do, Korea
Area of the site 146,013 m²
Area of the buildings 32,191 m²
Key facilities Production lines in the IV building, automated warehouses and utilities
Dosage forms of products Oral solid dosage products, Oncology Injectables and IV fluids
Certifications KOSHA-MS, ISO 45001, ISO 14001, KGMP

IV fluids

The environment-friendly smart factory features one of Korea’s largest production capacities and the latest automated facilities to ensure global quality standards are met.

IV fluids, cephalosporin antibiotics (finished products, APIs), general APIs are manufactured and supplied to domestic and international customers.

  • 01

    A CMO of over 20 years with a major Japanese pharmaceutical firm

  • 02

    Specialized technologies for IV fluid production and automated facilities that meet GMP standards

  • 03

    Production facilities entirely dedicated to the API of K-CAB tablets, Tegoprazan

  • 04

    Over 20 years’ experience in manufacturing antibiotics of aseptic processing

Address 20 Daeso Sandan-Ro, Daeso-Myeon, Eumseong-Gun, Chungcheongbuk-Do, Korea
Area of the site 58,278m²
Area of the buildings 28,411m²
Key facilities Twenty-five buildings including those dedicated for IV fluids, Tegoprazan, cephalosporin antibiotics, and TPN.
Dosage forms of products IV fluids, oral solid dosage products, API for cephalosporin, General API
Certifications KOSHA-MS, ISO 14001, KGMP, PMDA, Iran FDA

Tegoprazan

A building is entirely dedicated to the production of the API of K-CAB tablets, Tegoprazan.

IV fluids

The building features the latest automated facilities that meet GMP standards and a conveyer system.

Antibiotics
(Cephalosporin)

Contract manufacturing antibiotic API and supplying to Japanese originators

Antibiotics
(Cephalosporin API)

API for antibiotics of aseptic processing(cephalosporin) export to Japanese originators

With over 30 years of experience in manufacturing biopharmaceutical products, the Plant supplies its products to domestic and international customers.

  • 01

    Vaccine production facilities that are GMP-compliant

  • 02

    With over 20 products registered in a number of countries including Singapore and Thailand

  • 03

    A quality management system to ensure the manufacturing of premium quality products

  • 04

    Production technologies and hands-on experience from over 30 years in the industry

Address 811 Deokpyeong-Ro, Majang-Myeon, Icheon-Si, Gyeonggi-Do, Korea
Area of the site 34,751 m²
Area of the buildings 14,491 m²
Key facilities 10 buildings including those specialized for the production of vaccines and Epokine, and for quality management
Dosage forms of products Biological products (e.g. vaccines and genetic recombination drugs), antibiotic injections
Certifications KOSHA-MS, ISO 14001, KGMP, TFDA, MOH, Philippines FDA

Injections

Biological products and finished pharmaceutical products that meet the latest GMP standards are manufactured.

Epokine

With over 30 years of experience in manufacturing drugs, the source ingredients for biological products are manufactured.

Vaccines

Vaccines that meet the latest GMP standards are manufactured.

With the establishment of a highly reliable GMP Cell Center, HK inno.N has been leading the industry in the development and manufacturing of Advanced Therapy Medicinal Products.

  • 01

    One of Korea’s largest automated production facilities with a closed system

  • 02

    Cell & Gene Therapy production facilities that are GMP-compliant

  • 03

    A top-notch quality management system to ensure high quality products are manufactured

  • 04

    Infrastructure for the development and optimization of CGT processes

Address Building D, 947 Hanamdaero, Hanam-Si, Gyeonggi-Do, Korea
Area of the site Approximately 1,508 m2 or 457 pyeong
Key facilities Process development lab, Quality testing and analysis lab, Aseptic manufacturing room, Storage room
Product formats manufactured Advanced Therapy Medicinal Products (for Cell & Gene Therapy)
Permission Permission for Manufacturing Advanced Biological Products (2022.08)
Permission for Management Business of Human Cells (2023.09)

Process development lab

By developing and optimizing CGT processes, HK inno.N continues to increase its productivity.

Quality testing and analysis lab

Quality tests are conducted in accordance with the standards and regulations applicable to Advanced Therapy Medicinal Products.

Aseptic manufacturing room

A closed system consisting of automated facilities of some of the largest scales in Korea, set in a aseptic environment allows for CGT products of the highest quality to be manufactured.
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