Integrated manufacturing site specializing in cancer pain treatment drugs, and cephem/carbapenem antibiotics

The capacity of Kanegasaki Plant is approximately 100 tons/year for antibiotics API, 17 million vials/year for vial formulation and 420 million tablets/year for tablet formulation, where manufacturing is conducted under adequate confinement and aseptic technology to guarantee high quality to meet safety requirements and to give a sense of security to clients. Our past performance of clearing many overseas and domestic audits can assure our clients to place trust on us and enable smooth market introduction of products.

Kanegasaki Plant

7 Nishine Moriyama, Kanegasakai City, Iwasa-gun, Iwate 029-4503, Japan
TEL +81-197-44-5121

  • Japan
    Japan
    PMDA
    Oct. 2018
  • USA
    USA
    FDA
    Mar. 2019
  • EU
    EU
    EMA
    Jan. 2012
  • South Korea
    South Korea
    MFDS
    Jul. 2009
  • Saudi Arabia
    Saudi Arabia
    SFDA
    Jan. 2010
  • Taiwan
    Taiwan
    TFDA
    Aug. 2013
  • Brazil
    Brazil
    ANVISA
    May. 2009
  • South Africa
    South Africa
    MCC
    May. 2013

Cephem Antibiotics API/Intermediates Manufacturing Building

We manufacture high quality Cephem antibiotics API and intermediates. In Compliance with J-GMP, c-GMP, EU-GMP, and PIC/S GMP, the plant is capable of supplying products globally to the USA, EU and Asian countries in addition to domestic market.

  • Production Control System

    Production Control System

  • Multiple Large Capacity Reactors

    Multiple Large Capacity Reactors

General Work Area Major Facilities

Reactors 300~10,000L(SUS,GL)
Low Temperature Reactors 10,000L(GL,-80˚C)
Separators Centrifuge (Low Exhaust type): 60x40inch,48×38inch(TL)
Centrifuge (Top Exhaust type) 30inch (TL)
Pressurized Filtration Equipment: 1-6 m2(SUS)
Rectifying Column φ1,200×6,000(TL)
Continuous Rectifying Column: φ850×5,000(SUS)
Adsorbing Column φ850×2,500(TL)
Dryer Conical: 5,000L(GL), 6,000L(GL)

General Work Area Major Facilities

Reactor Crystallizer Reactor: 500L (GL)
Crystallizer: 1,000L (GL)
Separator Centrifuge (Top Exhaust type): 42inch (TL)
Centrifuge (Horizontal type): φ800(SUS)
Pressurized Filtration Equipment: 0.5m2(TL)
Dryer Conical: 300L(GL)
6,000L(SUS)
Fluidized Bed Granulator: Container Capacity 790L (SUS)
Filtration Dryer: 4m3(SUS)
Pulverizer Power Mill Oscillator (SUS)

Cephem Antibiotics Aseptic Formulation/Packaging Building

We have facilities for high quality cephem antibiotics injectable vial formulation (lyophilized formulation.) In compliance with J-GMP, c-GMP, EU-GMP, and PIC/S GMP requirements, we can manufacture high quality aseptic products for the global market.

  • Building

    Building

  • Three (3) units of largest-scale Lyophilizer in Japan

    Three (3) units of largest-scale Lyophilizer in Japan

  • Vial filling line

    Vial filling line

Major Facilities

Sterilization / Decontamination Autoclave, VHP sterilizer
Solution preparation system Solution preparation tank (350L, SUS), Automatic pH control system, Final mixing tank (1100L, SUS)
Redundant sterilizing filtration system
C/SIP systems
Vial Filling Line Vial Washer, Depyrogenation tunnel, Vial filling stoppering machine (solution)
RABS
300 Vials/min (φ24.5mm)
Lyophilizer Lyophilizer, Automated vial loading systems
60,000 Vials/unit (φ24.5mm)
Vial Capper RABS
300 Vials/Min (φ24.5mm)
Vial Exterior washing Exterior Washer
Inspection 100% visual inspection
Vial Packaging Vial packaging line
200 Vials / min (φ24.5mm)
(labeling, carton packaging, printing/inspection, weight check)
Serialization system

Cephem Antibiotics Solid Oral Formulation/Packaging Building

We have facilities for high quality cephem antibiotics solid oral formulation (tablets, capsules, granules.) In compliance with PIC/S GMP requirements, we can manufacture high quality products for the global market.

  • Tablet Press

    Tablet Press

  • PTP filling packaging line

    PTP filling packaging line

  • PTP packaging line

    PTP packaging line

Major facilities

Mixing Boat-shaped vibrating screen classifier
Dome shaped mixer
Sifting/Classifier Turbo cleaner
Trituration sifting equipment
Granulator Agitating granulator
Fluidized-bed granulator dryer (30 type, 120 type)
Cylindrical extrusion granulator
Roller compactor
Roll granulator
Solution mixing tank (600L, 1,500L)
Dryer Fluidized-bed dryer (120type)
Pulverization / Sizing Jet Mill, Power Mill, Pin Mill
FitzMill
Tableting Tablet Press (45 stations)
Capsule Filling Capsule filling equipment (200 type)
Capsule weight inspection equipment
Capsule exterior inspection equipment
Capsule band-sealing equipment
Coating Coating equipment (130 type)
Inspection Exterior inspection equipment (granules)
Printer Print inspection equipment (Tablet)
Printing Process Poly bottle/Glass bottle filling packaging line (fine grains)
Poly bottle filling packaging line (tablets)
SP filling packaging line (fine grains/granules)
Aluminum SP filling packaging line (Fine grains)
PTP filling packaging line (capsules/tablets)
Pre-stamper (variable GSI code)

Carbapenem Antibiotics API/Intermediates Manufacturing Building

We have facilities for high quality carbapenem antibiotics formulation (API and intermediates.) In compliance with J-GMP, c-GMP, EU-GMP, and PIC/S GMP requirements, we can manufacture high quality aseptic products for the global market.

  • Aseptic isolator

    Aseptic isolator

  • Vibrating dryer

    Vibrating dryer

General Work Area Major Facilities

Preparation Equipment 1,000L(SUS)
Reactor 300~4,000L(SUS,GL,HC)
Reactor Rectifier 1,500~3,000L(SUS,GL)
Extractor 1,000L(SUS)
Separators Centrifuge: φ900(HC)
Pressurized Filtration: 1.3m2(SUS)
Dryer Conical: 1,000 (GL)

Product Area major Facilities

Preparation Equipment 1,500L(SUS)
Reactor Crystallizer Reactor: 500L(SUS)
Crystallizer: 2,500L(SUS)
Solution Mixing Tank 1,200L(SUS)
Aseptic Facilities Depyrogenation ultrafiltration equipment: 50m2
Isolator:12.96m2
Autoclave: 1,300L(SUS)
Separators Centrifuge: 30inch(TL)
Pressurized filtration equipment: 0.15~0.78m2(SUS)
Dryer Vibration Fluid Dryer: 120L(SUS)
Fluid Dryer: 1,600L(SUS)

Carbapenem Antibiotics Aseptic Formulation/Packaging Building

We have facilities for high quality carbapenem antibiotics injectables vial formulation (Aseptic powder filled formulation.) In compliance with J-GMP, c-GMP, EU-GMP, and PIC/S GMP requirements, we can manufacture high quality aseptic products for the global market.

  • Outside View

    Outside View

  • Vial Powder Filling facility

    Vial Powder Filling facility

Major Facilities

Sterilization/Decontamination Autoclave, VHP sterilizer
Vial Filling Line Vial Washer, Depyrogenation tunnel, Accofil model Powder filling stoppering machine, Capper, Exterior Washer
RABS
120 Vials/min. (φ24.5mm, 29.5mm)
Inspection 100% Visual Inspection
Packaging Vial packaging line
110 Vials/Min. (φ24.5mm, 29.5mm)
(labeling, carton packaging, printing/inspection)

Cancer Pain Treatment Drugs API/Formulation (solid/injectables) / Packaging Building

We have manufacturing facilities for high quality cancer pain treatment drugs. In compliance with domestic API GMP, we can manufacture high quality products including injectable ampule formulation and solid oral formulation (tablets, powders.)