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케미컬페이지 비주얼이미지입니다.
Business

We will become the leader in the chemical field based
on our best technologies

  • Active Pharmaceutical Ingredients
    Provide APIs and intermediates for pharmaceutical companies worldwide from Kolon’s newest GMP compliant state-of-the-art facility
  • Specialty Chemical
    Supply pyrithione antimicrobials used for dandruff shampoos and antifouling agents to global clients
  • Water Solution
    Provide the total solution related to various water treatment chemicals based on polymer coagulants to sewage treatment plants and waste water disposal plants
Chemical 연구소 주요 연구 분야인 의약, SC, CA, WS를 표현한 비주얼이미지입니다.
  • 의약 아이콘입니다.
    APIs
    Generic API, intermediates for pharmaceuticals, CDMO&CMO
  • SC 아이콘입니다.
    Specialty
    Chemical
    Fine chemical products for
    personal care and industries
  • WS 아이콘입니다.
    Water
    Solution
    Polymer coagulant, eco-friendly water treatment agents
Analysis Equipment
  • FT-NMR
  • HPLC, HPLC-MS, GC
  • XRD, FT-IR
  • PSD
  • Dispersion stability analyzer
  • SEM
FT-NMR
Fourier transform - Nuclear magnetic resonance
HPLC, HPLC-MS, GC
HPLC : high-performance liquid chromatography
HPLC-MS : high-performance liquid chromatography - Mass Spectrometer
GC: Gas chromatography
XRD, FT-IR
X-Ray diffraction
PSD
Particle size distribution analyzer
Dispersion stability analyzer
SEM
Scanning Electron Microscope (SEM)
Lab Instruments & Equipment
  • Incubator
  • Fermentor
  • High pressure homogenizer
  • Laminar reactor
  • FBRM
Incubator
Fermentor
High pressure homogenizer
Larminar
FBRM
Focused Beam Reflectance Method
Analysis Equipment
  • FT-NMR
    FT-NMR
    Fourier transform - Nuclear magnetic resonance
  • HPLC, HPLC-MS, GC
    HPLC, HPLC-MS, GC
    HPLC : high-performance liquid chromatography
    HPLC-MS : high-performance liquid chromatography - Mass Spectrometer
    GC: Gas chromatography
  • XRD, FT-IR
    XRD, FT-IR
    X-Ray diffraction
  • PSD
    PSD
    Particle size distribution analyzer
  • Dispersion stability analyzer
    Dispersion stability analyzer
  • SEM
    SEM
    Scanning Electron Microscope (SEM)
Lab Instruments & Equipment
  • Incubator
    Incubator
  • Fermentor
    Fermentor
  • High pressure homogenizer
    High pressure homogenizer
  • Laminar reactor
    Laminar reactor
  • FBRM
    FBRM
    Focused Beam Reflectance Method
Overview

The API plant was completed in 2012 and is equipped with the newest facilities. It has been recognized as one of the leading API production plants in Asia. This plant is operated in two separate buildings to ensure stable supply.

충주공장 - 생산동 전경 이미지입니다.
Products
Various active pharmaceutical ingredients including anti-inflammatory analgesic drugs, antihypertensive drugs and anti-diabetics are produced through the processes including reaction, crystallization, filtration, dehydration, pulverization and packaging.
생산제품에 대한 이미지입니다.
Production capacity
The plant is equipped with stainless steel and glass-line type reactors in various sizes including 300L and 10,000L. 750 tons of active pharmaceutical ingredients per year and 300 tons of intermediates for pharmaceuticals per year can be produced.
생산제품에 대한 이미지입니다.
Certifications

The GMP system is operated and the BGMP approval was received from MHLW (Japanese Ministry of Health, Labour, and Welfare) and MFDS in 2013.

Type Certifications Certificate authority and country Year and month of acquisition
ESH ISO 45001:2018 Societe Generale de Surveillance(SGS) 2020.06
OHSAS 18001:2007 Soiete Generate de Surveillance(SGS) 2017.11
ISO 14001:2015 Soiete Generate de Surveillance(SGS) 2017.12
API Approval of Pharmaceutical Manufacturing License MFDS / Korea 2012.11
Approval of Accreditation of foreign drug manufacturer MHLW / Japan 2013.3
Certificate of GMP Compliance of a Manufacturer (Synthesis) MFDS / Korea 2013.6
Certificate of GMP Compliance of a Manufacturer (Extraction) MFDS / Korea 2018.6
Inspection for GMP Compliance of a Manufacturer PMDA / Japan 2018.12
API
Certifications : OHSAS 18001:2007
Certificate authority and country : Soiete Generate de Surveillance(SGS)
Year and month of acquisition : 2017.11
Certifications : ISO 14001:2015
Certificate authority and country : Soiete Generate de Surveillance(SGS)
Year and month of acquisition : 2017.12
Quality
Certifications : Approval of Pharmaceutical Manufacturing License
Certificate authority and country : MFDS / Korea
Year and month of acquisition : 2012.12
Certifications : Approval of Accreditation of foreign drug manufacturer
Certificate authority and country : MHLW / Japan
Year and month of acquisition : 2013.3
Certifications : Certificate of GMP Compliance of a Manufacturer (Synthesis)
Certificate authority and country : MFDS / Korea+
Year and month of acquisition : 2013.6
Certifications : Certificate of GMP Compliance of a Manufacturer (Extraction)
Certificate authority and country : MFDS / Korea
Year and month of acquisition : 2018.6
Certifications : Inspection for GMP Compliance of a Manufacturer
Certificate authority and country : PMDA / Japan
Year and month of acquisition : 2018.12
Quality Control Laboratory

The quality control tests for APIs and intermediates product are carried out here. 15 separate laboratories including an instrumental analysis laboratory, stability laboratory, microbiology laboratory and record center (document storage) are operated according to testing purposes.
The laboratories have approximately 40 physico-chemical and microbiological analysis instruments including HPLC, GC, UV and IR.

Overview

Approximately 20 high quality active pharmaceutical ingredients are produced based on experience and know-how accumulated over decades and the plant design is divided into two separate production buildings, thus supplying products to customers in a stable manner.

Products

Various active pharmaceutical ingredients including anti-inflammatory analgesic drugs, antihypertensive drugs and anti-diabetics are produced through the processes including reaction, crystallization, filtration, dehydration, pulverization and packaging.

Certifications

The GMP certification was received in 1998, and compliance with relevant standards and procedures was verified by Portugal Infarmed in 2010 and PMDA in 2011 based on site inspections.

Type Certification Certificate authority and country Year and month of acquisition
API Certificate of GMP Compliance of a Manufacturer MDFS / Korea 1999.11
Inspection for GMP Compliance of a Manufacturer PMDA / Japan 2011.4
Quality Inspection for GMP Compliance of a Manufacturer PMDA / Japan 2015.7
Inspection for GMP Compliance of a Manufacturer PMDA / Japan 2019.2
API
Certifications : Certificate of GMP Compliance of a Manufacturer
Certificate authority and country : MDFS / Korea
Year and month of acquisition : 1999.11
Certifications : Inspection for GMP Compliance of a Manufacturer
Certificate authority and country : PMDA / Japan
Year and month of acquisition : 2011.4
Quality
Certifications : Inspection for GMP Compliance of a Manufacturer
Certificate authority and country : PMDA / Japan
Year and month of acquisition : 2015.7
Certifications : Inspection for GMP Compliance of a Manufacturer
Certificate authority and country : PMDA / Japan
Year and month of acquisition : 2019.2
Overview

Gimcheon plant produces polymer coagulant used in the whole water treatment field including the treatment of service water, industrial water, industrial wastewater and sewage, along with a plant that produces pyrithione used as an antifoulant for lower hull paints, antimicrobial for plastics, and anti-dandruff agent for shampoo.

김천공장 전경 이미지입니다.
Certifications
Type Certification Certificate authority and country Year and month of acquisition
ESH ISO 14001:2015 Soiete Generate de Surveillance(SGS) 2017.12
ISO 45001:2018 Soiete Generate de Surveillance(SGS) 2020.06
Quality ISO 9001:2015 Soiete Generate de Surveillance(SGS) 2018.6
EFfCI GMP for Cosmetic Ingredients(2017) Soiete Generate de Surveillance(SGS) 2018.6
ESH
Certifications : ISO 14001:2015
Certificate authority and country : Soiete Generate de Surveillance(SGS)
Year and month of acquisition : 2017.12
Certifications : ISO 45001:2018
Certificate authority and country : Soiete Generate de Surveillance(SGS)
Year and month of acquisition : 2020.06
Quality
Certifications : ISO 9001:2015
Certificate authority and country : Soiete Generate de Surveillance(SGS)
Year and month of acquisition : 2018.6
Certifications : EFfCI GMP for Cosmetic Ingredients(2017)
Certificate authority and country : Soiete Generate de Surveillance(SGS)
Year and month of acquisition : 2018.6
  • Powder Coagulant
    Products

    This plant produces polymer flocculant in powder form.

    Production capacity

    The plant is operated 24 hours a day with processes including polymerization, chopping, drying, sieving and packaging taking place. The plant has a production capacity of 10,000 tons a year.

    • Liquid Coagulant
      Products

      This plant produces coagulant in liquid form.

      Production capacity

      It has a production capacity of 6,000 tons a year. flocculant is produced through processes including monomer make-up, emulsification, polymerization, inverting, filtering and packaging, and the product is packaged in 20kg cans, 1-ton IBC and 15-ton and 20-ton tank lorries.

    • High-purity Pyrithione
      Products

      This manufacturing plant produces high-purity pyrithione used as antifoulant for lower hull paints and antimicrobial for plastic.

      Production capacity

      High-purity pyrithione has been produced for 20 years through particle size and shape control technologies based on the study of morphology. Customer-specialized products in forms including powder, paste, solution and dispersion are provided to customers.

    • Zinc Pyrithione Suspension
      Products

      This manufacturing plant produces zinc pyrithione suspension used as anti-dandruff agent for shampoo.

      Production technology

      This plant is currently partnering with a global company through in relation to preservative formulation technology that overcomes the disadvantage of a single material and maximizes the antibacterial effect.

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